THAI NEWS AIDS 2007

     

 

 

 

 

 

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Religious beliefs hamper fight against Aids: Southern Muslims must accept the fact  - December 2, 2007

Religious beliefs have hindered the fight against HIV/Aids in the southern region, according to a recent study. The study says beliefs against condom use and little sex education make Muslim women and teenagers in this region a highly vulnerable group.

The stigma of being an Aids victim is a barrier in itself as it discourages Muslim sufferers all the more from seeking treatment.

"The condom use campaign for Aids prevention should not be promoted in Muslim communities since it is against Islamic beliefs of abstinence and faithfulness to one's marriage partner," said Amporn Marddent, an academic of the Walailuck University's Cultural Studies Programme School of Liberal Arts.

The research also shows that running Aids prevention and treatment campaigns in Muslim communities was a tough challenge for both the government and non-governmental organisations as most Thai Muslims still believe that only those having casual sex, and men having sex with men, could be at risk of HIV/Aids and that Muslims who strictly follow Islamic teachings had only a slim chance of contracting the virus.

Muslim women mostly contract the virus from their drug-addicted husbands.

There was also a higher infection risk among babies as most Muslim mothers gave birth at home and could not receive the necessary medication to prevent the transmission of HIV/Aids from mother to child, said Lawan Sarovat, deputy medical coordinator of Doctors Without Borders Thailand.

Of the total 13,936 new cases found in Thailand this year, 36% were housewives and female teenagers, followed by homosexual men at 24%, according to the latest report of the Public Health Ministry.

"It is evident that sex and intravenous drug use are still major problems contributing to the spread of Aids in Muslim communities," said Jirachote Sajjakul, coordinator of the Aids prevention campaign in southern provinces run by the Association of Thai Muslim Youth. "We have to accept this fact and seek appropriate solutions to deal with it."

Heroin, kratom leaves (Mitragyna Speciosa), ecstasy and codeine, a controlled substance made from opium used in cough mixtures, were also widely abused by young people in the South and more or less contributed to the spread of the virus.

Muslim men contract the virus from using injecting drugs during their teenage years and pass on the virus to their wives after marriage, Mr Jirachote said.

A survey in the three southernmost provinces by the Bureau of Epidemiology also showed that married couples were the most vulnerable group.

Schools in Muslim communities are downplaying the Aids threat by treating it as a taboo topic.

The national report also shows that as many as 77% of Thai teenagers had little knowledge of the disease, reflecting why about half of the 321,650 cases in the country were now between 25 and 34 years of age. Over half a million Thais are still living with HIV/Aids.

To solve Aids problems in Muslim communities, Mr Jirachote believes it was important for the government to come up with different projects for raising Aids awareness in the South.

Provincial Islamic committees in the South are considering whether mandatory pre-marital Aids tests are feasible. Such a practice is already in place in Malaysia's Johor state since 2001. The test results will go to the religious authorities.

If medically fit, the couple is allowed to get married. But otherwise, it is left to them to decide whether they should go ahead with the wedding and are not prevented from doing so.

Blindness in Aids patients not being diagnosed: MSF says drugs are too expensive  - December 2, 2007

Blindness in HIV/Aids patients in Thailand, Burma and Cambodia is linked to a failure to diagnose and treat cytomegalovirus retinitis (CMV), according to a recent study published in the journal PLoS Medicine yesterday. The Doctors Without Borders (MSF) have studied CMV retinitis, which has been dramatically reduced in wealthy countries since the advent of antiretroviral therapy, but still found in many patients with advanced Aids in Cambodia, Burma and Thailand with 23%, 27% and 32% of the total cases respectively.

"We can diagnose CMV retinitis fairly easily and reliably in less than two minutes, and there is an effective, practical treatment, if at least the CMV retinitis is mentioned in the current and pending WHO guidelines for HIV treatment in resource-poor settings, and if Roche kindly reduce more the price for the package," said one of the authors, Dr David Wilson, a former MSF medical coordinator in Thailand.

The study, which is based on the clinical experience of Medecins Sans Frontieres and other programmes assessed by Dr David Heiden, a consultant from the SEVA Foundation in San Francisco, said detecting and treating CMV retinitis early enough would stop the slow but relentless progress of a disease that leads to blindness within three to six months in patients whose immune systems are severely weakened.

But because there are often no symptoms in the early stages of the disease, CMV can only be diagnosed through the systematic screening of all at-risk patients.

Routine retinal examination of high-risk HIV patients in Burma helped save patients from CMV-related blindness, Dr Kalpana Sabapathy, an MSF HIV/Aids adviser, said. But in many countries the best treatment option is oral valganciclovir, which costs more than US$10,000 (about 308,000 baht) for a four-month treatment course, too much for people in developing countries.

"Until then, CMV retinitis will continue to be the neglected disease of the Aids epidemic," said Dr Tido von Schoen-Angerer, the director of MSF's Campaign for Access to Essential Medicines.

In Thailand, MSF and its local partners have decided to use the sub-optimal intravenous formulation of ganciclovir as well as intraocular injections.

Oxfam: Pharmaceutical industry is undermining its own future  - December 1, 2007

By keeping the traditional way of doing business that denies access to medicines to millions of poor people in developing countries, the pharmaceutical industry is undermining its own future, Oxfam says in its report.

The report, "Investing for Life", looks at the world's top 12 pharmaceutical companies, including their drug pricing policies, their record in developing medicines relevant to poor countries and their stance on protecting intellectual property rights.

Oxfam says the industry is failing to ensure universal access to medicines because it refuses to put the issue at the heart of its business model. As a result, it is failing to capture the full potential of emerging markets touted as the "new frontier" for its business success.

According to a major consultancy firm, loss of faith in the industry on the part of its investors has so far cost pharmaceutical shareholders $1 trillion.

"The industry is burying its head in the sand. More than 85% of the world's consumers are under-served or have no access to its medicines. The industry must recognise that charging high prices, quashing generic competition, developing medicines only for those rich enough to pay and fighting for harsher patent laws is an ineffective business strategy for new markets, as much as it is a moral outrage," said Jeremy Hobbs, Oxfam International executive director.

"Investors are worried about the industry's performance. They know that emerging markets are key for the industry's future growth, but companies have been responding to the challenge of breaking into emerging markets in an ad hoc and inconsistent way. This is bad for the industry and bad for poor people who are still facing devastating diseases like malaria, tuberculosis, asthma, cancer and HIV/Aids without affordable medicines,' Mr Hobbs said.

The report reveals shortcomings where the industry has failed to implement a systematic and transparent tiered-pricing policy, where prices for all essential medicines are set according to people's ability to pay.

More importantly, the investors continue largely to neglect research and development into diseases that predominantly affect poor people in developing countries.

They remain inflexible in protecting intellectual property, including challenging poor countries in court to stop them using legal public health safeguards. In addition, the investors continue to rely too heavily on donations to get affordable medicines to people, even though this is unsustainable and sometimes counter-productive.

Oxfam notes that some companies are offering differentiated prices but this is extremely limited and mainly for high-profile diseases such as HIV and Aids.

However, these offers are not systematic worldwide and are often still priced well above the means of people living in developing countries. Oxfam says that drug companies often adapt pricing in developing countries solely as a reflection of the publicity that surrounds the disease.

In Thailand, the industry failed to introduce pricing policies for key first and second line antiretroviral medicines that would enable sustainable treatment.

"The industry is operating in a short-sighted way because it could gain enormous benefits from emerging markets, including lower research and development costs and cheaper manufacturing. Yet instead it continues to blindly use its same strategies in poor countries. Even today, the richest 15% of the world consumes more than 90% of its pharmaceuticals. At this rate, both the industry and millions of sick patients are losing out," he concluded.

Teens have sex younger, but no condom: Ministry: Rate of Aids infection falls by 90%  - November 30, 2007

Young people are having sex younger but fewer than half use condoms, according to a report by the Public Health Ministry.

The ministry surveyed the sexual behaviour of youths last year and found fewer than half who admitted they had casual sex said they used condoms.

The average age of youths who had sex for the first time was 15, according to the survey, a drop from 18 in previous studies. About 36% of the males and 28% of the females in the surveyed group said they had sexual experience.

The findings have been released to coincide with World Aids Day today.

The World Health Organisation's (WHO) motto to raise awareness about Aids prevention this year is "Stop Aids. Keep the Promise".

The figures from the ministry highlight concerns about the continued spread of sexually transmitted diseases, as well as the increasing numbers of unwanted pregnancies and school dropouts.

The ministry said only 23% of male teens and 26% of female teens had been educated about Aids.

Dr Somchai Pinyopornpanit, deputy director-general of communicable disease control, said some teenagers had sex to win acceptance from their peers. Many were under the impression that HIV/Aids only infects commercial sex workers.

Dr Somchai was speaking after the opening of the ministry's anti-Aids campaign yesterday at Wachira Benjathat park in Bangkok.

He said many teenagers thought it was safe to have sex with friends or someone they knew personally, so they did not feel the need to use condoms.

Patchara Siriwongrangsan, director of the office for the prevention of Aids, tuberculosis and sexually transmitted diseases, said the ministry began a project to educate youths about prevention of the disease with youth leaders from 52 schools in 15 provinces last year.

The provinces under the programme include Bangkok, Trat, Kanchanaburi, Nakhon Sawan, Samut Prakan, Nonthaburi, Chiang Mai, Lampang, Surin and Udon Thani.

More than 28,000 teenagers have undergone training in Aids prevention under the project.

Dr Patchara said her office has also launched Aids prevention activities in 16 communities and set up Aids prevention clubs in 11 schools nationwide.

Dr Somchai said there were about 39.5 million Aids patients in the world last year.

About 2.9 million died.

This year the WHO estimates there will be about 4.2 million new infections.

In Thailand, the number of new Aids infections this year is expected to be well down, from 140,000 cases in 2004 to 14,000, he said.

Of the 14,000 new HIV carriers this year, the largest single group, or 45%, is female teenagers and married women. About 20% are homosexuals, he said.

Prior to this year the Public Health Ministry estimates about one million Thais had contracted the Aids virus. More than 558,000 of them had died, he said.

Saving children from infectious diseases  - November 15, 2007

From today till Saturday, leaders in the fields of pediatrics, immunology and general medicine are gathering in Bangkok for the 5th World Congress of the World Society for Pediatric Infectious Diseases (WSPID), to explore how scientific innovation can improve the lives of people across the globe. Here, some of the world's greatest medical minds will contemplate two vastly different scenarios facing the world in regard to stopping infectious diseases in children.

For the haves, the situation is stable. Affluent, industrialised nations enjoy access to life-saving vaccinations. In countries like the United States, France and Spain, inoculations have become routine, with new vaccines quickly made available to protect the most vulnerable - our children. For the have-nots, the situation is dire. Without dramatic action on a global scale to expand access to existing vaccines and accelerate the development of new ones, leading childhood killers will continue to take lives.

The most common of these killers is pneumococcal disease, which causes pneumonia, meningitis and sepsis, and claims the lives of 1.6 million people annually, half of whom are children under the age of five.

Sadly, children with HIV/Aids are up to 40 times more likely to get pneumococcal disease, and in Thailand where rates of HIV/Aids are high, pneumococcal disease places an additional burden on the national health system.

History with new vaccines shows us that we face two major challenges. First, we must encourage the development of vaccines that are needed in developing countries. Second, we must make sure that once developed, these vaccines are scaled up and rolled out to the children who need them the most. In the past, it often took 15-20 years for life-saving vaccines to reach even 20% of the children in the world's poorest countries.

Traditionally, the challenge has been ensuring that vaccines are developed to meet the needs of poorer nations and are accessible for those who are least able to pay. Today, new funding mechanisms and partnerships are working to overcome these obstacles. By investing directly in the development of vaccines, governments and philanthropies are assuring that researchers discover new vaccines against old scourges like TB and malaria. Similarly, by providing funding to assure there will be a credible market for these vaccines in poor countries, these same donors enable developing countries to access these vaccines earlier and at more affordable prices. These funding advances have created a tremendous opportunity to save lives, and the time for action is now.

This is precisely the charge of the Pneumococcal Awareness Council of Experts (PACE), an international working group of 15 of the world's leading experts in infectious disease and vaccines chartered to raise awareness of pneumococcal disease and advocate for its prevention. PACE is leading the call for increased cooperation among physicians, lawmakers, heads of state and drug makers to create vaccines and distribute them to the neediest nations.

Drug makers and governments have to join forces to find market-based solutions for market-based problems that have hindered vaccine production. The general public must make vaccine creation and distribution a top-priority item on the world's health improvement agenda, and remind our world leaders that the price of inaction is counted in lives lost needlessly to preventable diseases.

The above article has been co-authored by Dr Somsek Lolekha, President of the Medical Council of Thailand; Dr Ron Dagan, PACE Council Member and Professor, Pediatric Infectious Diseases Unit, Soroka Medical Centre and President of WSPID; and Dr Ciro A de Quadros, PACE Co-Chair and Executive Vice-President, Sabin Vaccine Institute.


Protest called over changes to drug law  - November 12, 2007

The Government Pharmaceutical Organisation's (GPO) labour union and consumer rights groups will rally at the Public Health Ministry today to protest against the government's planned abolition of the state drug firm's right to stockpile necessary drugs for public use.

The demonstration is backed by local and international labour and health advocacy groups, including the Rural Doctors' Club and the International Federation of Chemical, Energy, Mine and General Workers' Unions (ICEM).

The ICEM circulated a worldwide statement yesterday supporting the GPO labour union and Thai civil groups' demands for the dismissal of the draft decree that will halt the GPO's special status for securing drugs for public and emergency uses.

The draft decree was approved by the government last month and is now being scrutinised by the Council of State.

"We believe that removing the government as a provider of essential health needs, in any form, is a recipe for higher costs, with a bigger portion of the population going without adequate health care," ICEM general-secretary Manfred Warda said in his statement.

Rawai Pupaga, the GPO's labour union president, said the government procurement of pharmaceuticals is first and foremost for the benefit of needy citizens.

"It is not an urgent matter to change the procurement procedure now. There should be a public hearing so that other stakeholders can air their views," said Mr Rawai.

Vichai Chokewiwat, the GPO board chairman, said the board shared the union's views and added that any decisions on streamlining the government procurement process should be thoroughly considered and not rushed.

Dr Vichai said the decree, if enforced in its current form, would adversely affect the government's compulsory licensing scheme, which aims to enable the GPO to procure life-saving drugs for killer diseases such as Aids and cancer at affordable prices.

Life insurer has a responsibility - November 7, 2007

American International Assurance, a subsidiary of global insurance giant AIG, must come forward and clearly explain its policies towards homosexuals. So far, executives have walked a fine line between claiming that the company does not discriminate against homosexuals while saying that a person's "lifestyle" could affect whether they get coverage.

This is not good enough. AIA has a responsibility to do all it can to avoid discrimination, and must state explicitly why certain individuals are denied coverage or forced to pay higher premiums. If the company claims all homosexuals have "lifestyles" that make them riskier clients, then executives must explain exactly what they are talking about.

If it claims, for instance, that homosexuals are more promiscuous than straight people and thus more susceptible to terminal illnesses like Aids - which is certainly the implication when executives start linking homosexuality to "lifestyle" issues - then they must base this on some legitimate fact-based research. Studies show that gay men in Thailand are in fact not the highest risk group when it comes to new HIV infections. In what may come as a surprise to some, housewives are twice as likely to become infected in Thailand, according to a 2005 report by the Disease Control Department. The DCD report found that about 40% of new infections were married women who caught HIV from their husbands, while 22% were from men who had sex with men. Another 10% were married men who contracted HIV from their wives.

Last month, Deputy Public Health Minister Vallop Thaineua said the number of new HIV infections in young women and housewives would likely rise to 45% of the country's total new infections this year, while the number of new infections among men who have sex with men was expected to drop to 20%. It is a bit surprising that AIA still leaves itself open to allegations of discrimination since the debate about whether an insurance company can deny someone coverage based on sexual orientation ended in the United States two decades ago. In late 1986, the National Association of Insurance Commissioners came up with a policy stating: "Sexual orientation may not be used in the underwriting process or in the determination of insurability."

The debate turned to focus on whether insurance companies could take blood tests before deciding whether to cover a homosexual. But here in Thailand it is unclear if AIA even lets homosexual applicants get to that stage. Thailand's largest life insurer certainly denied coverage to the wrong man when it rejected the application of long-time gay rights advocate Natee Theerarojnapong, president of the Gay Political Group of Thailand. In June, when the Constitution Drafting Assembly agreed to recognise the rights of gays and lesbians by stating in Article 30 that differences in "sexual identity" could not be grounds for discrimination, Mr Natee wept. "This is what we have fought for for decades," he said.

Mr Natee is not the first gay person to accuse AIA of discrimination. In 2001, Somsak Chalachon, owner of Chalachon Hair Studio, alleged that AIA denied him coverage even after he passed a medical exam simply because he was gay. AIA responded by saying it could not disclose "personal client information" (even to the client, apparently) and said it denied coverage for "high-risk lifestyles". Although that case faded away, Mr Natee is taking his case to the Administrative Court in one of the first major tests of the new constitution. This may force AIA and other life insurers to become more transparent in their policies towards homosexuals.

While Thailand is generally much more open to homosexuals than other countries, individual cases of discrimination still exist - including the incident earlier this year when Novotel barred a transvestite from entering its nightclub. For all the progress that's been made over the years, homosexuals and transvestites still face social stigma. Each time a company like AIA, Novotel or any other takes a clear stand against discrimination of any kind, society as a whole will benefit.

Gays accuse AIA of discrimination: Company says it protects against 'risk'  - November 6, 2007

Gay activists have launched a protest against American International Assurance for unfair discrimination based on sexual preference.

AIA executives said the company had no explicit policies against homosexual clients, but reserved the right to consider applications based on risk factors related to "personal lifestyle".

Natee Teerarojjanapong, the president of the Gay Political Group of Thailand, said his application to purchase life insurance from AIA, the country's largest insurer, had been rejected solely because of his sexual orientation.

He said this was a clear violation of Section 30 of the 2007 constitution, which outlaws discrimination on the basis of race, language, sex or health.

Mr Natee yesterday submitted a complaint to the Insurance Commission and vowed to file a petition to the Administrative Court if he did not receive a response within the next couple of weeks.

He also called on the office to investigate whether other insurers also adopted such practices, and planned to co-ordinate with gay-rights advocates such as the Bangkok Rainbow Organisation to launch a global campaign against AIA.

"We condemn AIA's policy in Thailand for unfair discrimination. If AIA executives deny such practices, I will be happy to bring hundreds of homosexuals to the company to apply for insurance," Mr Natee said.

He claimed that on Oct 28, he applied for a life insurance policy with AIA agent Pachara Pipatwong, who later informed him that the company had a policy to deny insurance to gays and transsexuals.

Mr Natee added that he previously held life insurance policies with both Muang Thai and ING and that neither had ever asked about his sexual orientation.

AIA senior vice-president Sutti Rajitrangson denied that the company had any explicit policy against homosexuals. AIA was open to all applications without discrimination against any particular group of persons, he said.

But AIA reserved the right to evaluate policy coverage, premiums and set other conditions for clients in high-risk jobs or with high-risk lifestyles.

"Life insurance is a risk-management tool for the public. Underwriting criteria is thus based on risks met by the general population," Mr Sutti said.

"Anyone found to have higher risk than the general population could face higher premiums, limits in protection, restrictions on riders or even denials of their applications."

Mr Sutti added in a statement that the company's applications were judged based on various factors, including sex, age, occupation, health history and lifestyle.

"Out of our 5.8 million policyholders, we have persons belonging to high-risk groups as well. These policies were written based on our evaluation procedures and criteria," he said.

Insurance insiders say it is not unusual that companies would take steps to limit their potential liability for high-risk groups, such as smokers or persons with past drug addictions.

One AIA agent said customers are asked to fill out questionnaires to help the company assess potential health risks.

The Aids epidemic in Thailand is certainly one major public health threat faced by insurers.

Many firms require Aids tests prior to offering coverage, particularly for persons from higher-risk jurisdictions such as in the northern provinces where Aids is a particular problem.

Generic AIDS medicine from India wins nod - October 17, 2007

The Food and Drug Administration has approved the registration of the second-line Aids drug lopinavir/ritonavir for use under the compulsory licensing policy.

FDA secretary general Siriwat Thiptaradol yesterday said the drug has passed the registration process which took more than three months to complete.

The newly-approved medicine is a generic version of Aluvia, a heat-stable form of second-line Aids drug Kaletra. Both Aluvia and Kaletra are produced by the US-based Abbot Laboratories.

The government in January announced the compulsory licensing policy to bypass patents of the original versions of the second-line Aids drugs.

However, the drugs' patent holder, Abbot Laboratories, opposed the move and offered to cut the price of Kaletra to $1,000 (32,500 baht) per patient per year on a condition that the Public Health Ministry revoke its CL policy.

The ministry rejected the offer, prompting Abbot to freeze registration of Aluvia in Thailand.

GPO board chairman Vichai Chokewiwat said the agency would soon import the first lot of lopinavir/ritonavir from India's generic drug maker Matrix Laboratories.

The amount would be enough for 8,000 HIV-positive people for the next six months.

The price quoted by the Indian drugmaker was at 24,324 baht (US$695) per person per year (2,027 baht per person per month).

Meanwhile, leading cancer drug producers Novartis, Roche Laboratories and Sanofi Aventis will meet the government's price negotiation panel, led by Dr Siriwat, tomorrow to discuss the possibility of a price reduction.

The talks would be the first between the government and the world's leading cancer drug makers after the National Health Security Office last month asked the Public Health Ministry to consider overriding the patents of four cancer drugs - imatinib, letrozole, docetaxel, and erlotinib - as their prices were considered too high.

HIV/AIDS: Study prompts concern about side effects of antiretrovirals  - October 15, 2007

Metabolic abnormalities caused by side effects from antiretroviral drugs are becoming increasingly prevalent among Thais living with HIV/Aids, recent studies have found.

According to a pilot study by Ramathibodi Hospital's Faculty of Medicine, published in the Journal of the Medical Association Thailand, the long-term toxicity of antiretroviral treatment has become more recognised through a variety of metabolic abnormalities including lipodystrophy, which affects body fat, and dyslipidemia, which affects the blood.

The latest study, conducted among 56 patients at the hospital, showed a high prevalence of lipodystrophy and dyslipidemia in Thai patients undergoing antiretroviral treatment.

More than 66% of the patients that took part in the study experienced health problems such as high levels of fat in their blood, high blood pressure, abnormal fat redistribution, cardiovascular and kidney disease, diabetes, and insulin resistance.

"In the past, people living with HIV/Aids tended to suffer from diseases such as tuberculosis and hepatitis C, but now non-communicable diseases have become increasing problems among HIV-positive people dependent on anti-Aids drugs," said Wisit Prasithsirikul, a medical researcher at the Bamrasnaradura Infectious Disease Institute.

Dr Wisit also conducted a study in 2004 and found similar results.

Many patients under the institute's antiretroviral treatment programme for over five years have experienced a high rate of lipid and glucose metabolism abnormalities, which are the major risk factors of cardiovascular and kidney diseases.

The institute, which specialises in treating HIV/Aids patients and communicable diseases, provided free medical treatment for 3,000 HIV-positive patients before the National Health Security Office would include the locally produced anti-Aids drug GPO-VIR in the universal healthcare scheme.

Of the estimated 500,000 people living with HIV/Aids in Thailand, 100,000 are dependent on anti-Aids drugs.

A researcher said his team of researchers are working on a large-scale study to better understand the effects of each anti-Aids drug prescribed for HIV-positive patients under the treatment programme at the institute.

He believed it was essential to conduct clinical monitoring among HIV-positive patients depending on ARV drugs under the universal healthcare scheme in a bid to better understand their effect on the prevalence of these abnormalities.

Nutrition counselling should also be provided for HIV individuals so that they can be more aware of the effects the treatments they are taking have on their bodies and their health.

Thailand To Build Anti-AIDS, Anti-Bird Flu Drug Factory - October 11, 2007

Bangkok - Thailand will build a pharmaceutical plant that will produce drugs to fight Acquired Immune Deficiency Syndrome, avian influenza, and manufacture other emergency medicines.

India will help Thailand build the plant in 18 months and at a cost of more than $27 million.

Thailand's Public Health Minister Dr. Mongkol Na Songkhla disclosed the plan during the signing of a business and trade agreement between the Government Pharmaceutical Organization of Thailand and the Hetero Drugs Co. of India.

The GPO produces cheap medicines for emergency crisis in Thailand. Hetero Drugs is a licensed manufacturer of a generic anti-bird flu drug.

Under the same agreement, the Indian firm will help Thailand plan the anti-AIDS drug factory and design the facility according to World Health Organization standards. The WHO standard will allow Thailand to sell the anti-AIDS medicine to member countries of the organization.

The Thai plant is projected to make two billion tablets a year.

Lack of funds halts condom ad campaign  - September 25, 2007

The Public Health Ministry's controversial Yued Ok Pok Thung TV ad campaign aimed at promoting condom use among teenagers will be halted after Oct 12 due to budget problems.

"We don't have the budget to continue the commercials on television. However, we will promote the condom campaign through other activities instead," said Disease Control Department chief Thawat Sundarachan.

Anupong Chitworakarn, director of the Global Fund in Thailand, insisted the "proud to carry condoms" campaign would not be cancelled completely.

But he said the project will be promoted at schools and educational institutions via other activities such as exhibitions and concerts instead when the commercial contract ends. The department receives the budget to run the TV commercial from the Global Fund.

The two versions of the advert - teenagers and adults buying condoms over the counter at a convenience store, and teenagers seeing health officials at community clinics to get condoms - have been on air for over two months. But some conservative public groups have criticised them saying they damaged Thai culture and even encouraged teenagers to be sexually active. They asked the broadcasting authorities to air the adverts after 10pm.

However, a group of 30 teenagers representing the Thai Youth Network on HIV/Aids and a network of people living with HIV/Aids defended the commercials saying they were well-intended and did not encourage teenagers to engage in sexual activity. They also disagreed with the idea of running the ads after 10pm.

Yesterday, they submitted a letter to Public Health Minister Mongkol na Songkhla to keep the commercials running.

"The ad has provided us with opportunities to communicate more with our parents on the topic of sex which should not be regarded as taboo any longer," Supawat Kiewkad, 16, from Makkasan Witthaya school, said it should be an obligation for young people to carry condoms to protect themselves and their partners from unwanted pregnancies, HIV/Aids and other sexual diseases.

Cancer drugs targeted for compulsory licensing - September 24, 2007

The National Health Security Office will ask the Public Health Ministry to consider overriding the patents of four cancer drugs to help patients under the universal health care scheme.

A panel chaired by secretary-general Sa-nguan Nittayarumphong will recommend the ministry approach the two drug companies concerned with an ultimatum - negotiate a price reduction or face compulsory licensing.

The four cancer drugs are imatinib, docetaxel, erlotinib and letrozole. They have been selected from 10 groups of expensive medications, including antibiotics and diabetes drugs.

The drugs are used to treat various types of tumours, including breast and lung cancer - a predominant cause of death in Thailand, Dr Sa-nguan said.

Several thousand cancer patients were already being treated under the universal health care scheme, formerly known as the 30-baht scheme, which covers 48 million people.

The health office wants cancer treatment to be more accessible to patients.

"We could get a low-priced version of letrozole which is 40 times cheaper than the patented drug," said Dr Sa-nguan.

Letrozole is a hormonal therapy marketed as Femara.

If the ministry agreed with the proposal, a negotiating team led by the Food and Drug Administration secretary-general would discuss prices with the drug companies.

He said the ministry should first opt for "voluntary licensing" to avoid complaints of unfair treatment from drug companies. If negotiation fails, then compulsory licensing should follow.

Earlier this year the ministry announced a compulsory licensing policy for the Aids drugs Efavirenz and Kaletra, and heart drug Plavix.

Compulsory licensing is allowed by the World Trade Organisation in case of a "national emergency". This lets the ministry bypass drug patents and import or produce generic versions of patented drugs for non-commercial purposes.

THAILAND: STDs Are Spreading Fast Among School Girls -  September 21, 2007

A survey of 13,429 students in 24 Thai provinces showed that more than 50 percent of the group did not use condoms during sex, which could put them at risk of infectious diseases. Somyot Kittimunkong, head of the AIDS Cluster Division, said most vocational school girls sampled had gonococcal urethritis.

Somyot said the incidence of infections, especially among teenagers, was increasing because the government no longer launches intensive prevention campaigns, having scaled down HIV/AIDS prevention efforts over the past four years. The Public Health Ministry, for budget reasons, has also shut down STD clinics, which offered disease-prevention information to HIV patients and teens.

The clinics' work was transferred to public hospitals. However, "Most hospitals lack an expert who could counsel youths or even adults with HIV," Somyot said, "so they don't have any correct information or feel confident in using condoms."

The ministry's recent campaign to convince people to carry condoms has met with criticism. Ladda Thangsupachai, director of the Culture Ministry's Culture Surveillance Center, said the Public Health Ministry's message, if not clear, could lead to misunderstandings about what condoms are used for.

Sujittra Prongsang of the Bureau of Vocational Education Standards and Qualifications at the Education Ministry said society must understand that teen sex is not an embarrassment, and condoms work to protect them from disease if they do have sex.

Be open-minded over condom use among teens, public urged  - September 19, 2007

Sex education and women's rights advocates have called for the public to be more open-minded about young people carrying condoms as it is an effective means to protect themselves and society.

The group defended the health ministry's controversial TV campaign spots Yued Ok Pok Thung (Proud to carry condoms) as being well-intended and not being about teenagers' sexual desires.

The issue was discussed at a seminar held by the Thai Health Promotion Foundation following widespread criticism of the campaign, which has been on free TV for two months.

Critics, including some NGOs and members of the public, said the TV spots, which encourage youths to carry condoms wherever they go, have damaged Thai culture and even encouraged teenagers engaging in sexual activity.

But participants at the seminar mostly agreed that sex is commonplace in today's society and it should even be a "duty" of young people to carry condoms to protect themselves and their partners from unwanted pregnancy, HIV/Aids and other sexual diseases.

Somyos Kittimankong of the Department of Disease Control said society can no longer deny that teenagers are a high-risk group for contracting HIV/Aids despite the fact that condoms are easier to buy than in the past.

He cited a study of the sexual behaviour of 13,429 Matthayom 5 (Grade 11) students in 24 provinces last year, which found that less than half the male students used condoms when they had sex for the first time, while only 43% of female students made their partners use condoms while having sex.

Places where teenagers get condoms include convenience stores, public health centres, pharmacies and condom-vending machines.

Dr Somyos said Thailand was entering the second phase of an HIV/Aids pandemic with new infections continuing to increase. More action, including condom use campaigns, was needed.

Sararee Sae-Iaw, head of the Bali Hai vocational youth group from Chon Buri, said most teenagers in her group did not feel any special desire for sex after seeing the TV spots.

"Condoms are common things, and seeing them has nothing to do with our sexual desires," said Ms Sararee.

Nathapong Suksiri, of Youth Net against HIV/Aids, said since the TV spots began teenagers felt more at ease buying condoms at convenience stores or getting them from community health centres.

"I think the spots make them feel more responsible for themselves and for society by carrying condoms," Mr Nathapong said.

Ladda Tangsuphachai, director of the Culture Watch Centre of the Culture Ministry, said she was not against the condom campaign, but felt it may be too soon for everyone to accept the idea.

"I believe no parents want their children to have sex before graduation. Besides, parents are different. Some understand the issue better, but some don't.

"Working with parents who have doctorates and those who are market vendors requires different strategies. Any educational media should be made acceptable to every group," said Ms Ladda.

Clarification about HIV vaccine trial  - September 18, 2007

We thank the Bangkok Post for its interest in the Phase III HIV vaccine study being performed in Rayong and Chon Buri provinces. However, we wish to clarify several of the statements in the article "Final phase of Aids vaccine trial extended" (July 31, 2007) for your readers.

The article states: "The final phase of an Aids vaccine trial in Thailand will be extended for another two years..." Actually, the Phase III HIV vaccine trial is not being "extended"; rather, the trial is scheduled to end in the summer of 2009 as planned.

At its July 18-19 meeting, the Data and Safety Monitoring Board (DSMB) recommended to the sponsor, the US Army Surgeon-General, that the trial should continue. It made a similar recommendation at each of the six previous meetings in its role as the independent data monitoring committee.

A statement from the sponsor dated July 20, 2007 is posted.

The last DSMB meeting was special because it was an "interim analysis", the only time before the end of the trial when the data are reviewed to see whether the data collected so far have shown that the vaccine prevents HIV infection.

Only the DSMB has access to this information. It is unusual for a DSMB to stop a trial early, so the recommendation to continue the trial was expected.

The article stated that the goal of this research was to "make the vaccine 80% effective after two years of research". This statement is not correct.

The trial has two objectives: 1) to show that the vaccine reduces infection by 50% compared to placebos; and 2) to show that vaccinated persons who acquire HIV infection through risk behaviour have a reduction in the amount of virus in their blood (viral load).

The article also noted that the "latest results showed only about 50-60% effectiveness".

The DSMB does not provide information on vaccine effectiveness to any person outside its membership. The investigators and sponsor will not know the level of vaccine effectiveness until the end of the trial.

The DSMB simply recommended that the trial be continued. No additional information was provided.

A few minor points should also be mentioned. The sponsor of the trial is the US Army Surgeon-General. The US Army and National Institute of Allergy and Infectious Diseases fund the study. The Ministry of Public Health executes the trial and provides clinical infrastructure and human and technical expertise to conduct the study.

Other collaborators include Mahidol University, the Royal Thai Army, Sanofi-Pasteur, and VaxGen.

There have been many smaller clinical tests of vaccines similar to the combination used in the Phase III trial; these other trials were conducted in North America, South America, the Caribbean and Europe.

A smaller test of this exact combination was conducted in Thailand by investigators from the Royal Thai Army, Mahidol University and the US Army.

There have been only two other Phase III "efficiency" trials conducted for Aids vaccines. Both were conducted with vaccines from VaxGen, called AIDSVAX.

One of those trials was conducted on intravenous drug users in Bangkok. The article mistakenly suggests that vaccine was 50% effective; AIDSVAX alone did not prevent HIV infection.

We thank you for the opportunity to clarify the matter.

DR SUPAMIT CHUNSUTTIWAT, Deputy Director, HIV Vaccine Phase III Trial, Ministry of Public Health

THAILAND: AIDS Hospice at Thai Buddhist Temple Adds Free Clinic for Life-Extending Care -  September 07, 2007

Since 1992, thousands of Thais dying with AIDS have sought hospice care at the Buddhist temple Wat Phrabatnampo-Center of Hope in Lopburi, 70 miles north of Bangkok. On Aug. 31, the temple opened a free clinic to dispense antiretroviral drugs to treat the disease, project leaders said.

The new project will extend treatment and support to keep relatively healthy people with AIDS alive, according to a statement by the temple's Dramaraksa Foundation, the Lopburi provincial government and the California-based AIDS Healthcare Foundation (AHF).

According to UN estimates, 330,000-920,000 of Thailand's 65 million people have HIV.

"The number of HIV patients has continued to rise and increase rapidly, and many people are in need of [antiretroviral] medicines and better treatment and care services," said Dr. Wichai Thaitaworn, director of the Dramaraksa Foundation. "We therefore must expand our services for HIV/AIDS patients and serve their needs more effectively."

Thailand's government provides virtually free antiretroviral treatment for most people with AIDS, but the center's new project will also cover the cost of other medicine, Wichai said. The project is expected to have one physician, a nurse, and a pharmacist.

AHF President Michael Weinstein praised Thailand's leadership in its fight against HIV/AIDS, and he said he hopes this project is the first of many AHF will work on in the country. "It is my heartfelt wish that in addition to providing quality antiretroviral treatment and care services, these centers also contribute to a greater understanding of HIV/AIDS and help reduce the stigma that many of those living with the disease have encountered," Weinstein said.

EU Scolds Thailand for Violating Patents on AIDS Drugs -  September 05, 2007

In a July 10 letter to Thailand's minister of commerce, European Commissioner for Trade Peter Mandelson expressed concern about Bangkok's "approach to access to medicines," specifically Thailand's policy that drug companies must offer their medicines at no more than 5 percent above the cost of generic versions.

"This approach would be detrimental to the patent system and so to innovation and the development of new medicines," Mandelson told the minister, Krirk-krai Jirapaet.

In 2001, the World Trade Organization (WTO) stated that intellectual property rules should not hamper countries from addressing public health emergencies. Mandelson said he supports the declaration, but noted it does not "appear to justify a systematic policy to apply compulsory licenses whenever medicines exceed certain prices." He asked Thailand to enter into direct discussion with companies holding the rights to certain drugs rather than threaten to overrule the patents.

In reply, Jirapaet said both WTO rules and Thailand's 1991 Patents Act allow government agencies to use compulsory licenses without prior authorization from the patent holders. Thailand has an estimated 600,000 HIV patients and has recorded approximately 300,000 AIDS deaths.

Last November, Thailand broke a patent on efavirenz, manufactured by Merck Sharp & Dohme. In 2007, it overruled patents on Kaletra, made by Abbott.

Compulsory licenses are particularly important in ensuring that HIV/AIDS patients have access to second-line treatments in case of drug resistance. In 2006, the World Bank predicted that the Thai government's use of compulsory licenses would reduce the cost of second-line drugs by 90 percent, a savings of $3.2 billion over 20 years.

Doctors Without Borders protested Mandelson's call on Thailand, saying it "blatantly ignores basic public health safeguards" agreed upon by WTO.

Drug giant threatens Indian firm with court  - September 1, 2007

Giant drug firm Sanofi-Aventis has threatened to take legal action against an India-based drug manufacturer if it supplies copycat versions of its patented heart drug Plavix to Thailand.

The move, exposed yesterday by Vichai Chokevivat, chairman of the Government Pharmaceutical Organisation (GPO) board, is seen as the latest attempt by the drug giant to obstruct Thailand's controversial compulsory licensing moves.

Dr Vichai, who chairs a committee overseeing the government's compulsory licensing policy, said a Thai agent of the Indian drug firm Emcure Pharmaceuticals recently asked the Public Health Ministry to confirm that buying clopidogrel, a generic version of Plavix, from the firm was not a violation of patent law as claimed by Sanofi-Aventis.

The pharma giant has said selling clopidogrel to Thailand is illegal since the country had not made public its decision to override the patent.

However, Dr Vichai strongly denied the allegation and insisted that the ministry had officially declared its policy on the compulsory licensing of Plavix.

"The firm's remark is groundless and it will not be able to back its legal action against the generic drug manufacturer and supplier," said Dr Vichai.

The ministry, he said, would send a letter to Emcure and the Thai agent confirming that the ministry issued compulsory licences for Plavix and Kaletra, an advanced anti-Aids drug, on Jan 25 this year, for local production or import from overseas.

The ministry last week decided to import the generic drug for patients with heart disease from Emcure Pharmaceuticals, which offers clopidogrel at 1.01 baht per tablet, against the market price of 70 baht per tablet.

Plavix, a blood thinner, is used to treat coronary artery, peripheral vascular and cerebrovascular diseases.

He said that Sanofi-Aventis' threat would not affect the procurement agreement in which a first batch of 2 million heart drug tablets will be shipped in two months.

A UN-backed project is helping HIV-positive women retain their independence through micro-credit sche - August 26, 2007

As an HIV-positive widow in Cambodia, Srim Phan had no hope. That was until she was encouraged to form a group, take a loan from a micro-credit scheme and start a sewing factory.

Her life has since changed for the better, she said.

The scheme is modelled on a critically acclaimed programme known as the Positive Partnership Project, launched in Thailand by the Population and Community Development Association (PDA).

In 2006, the United Nations Development Programme (UNDP) used the PDA as a model for a pilot project to economically empower HIV-positive women. It helps the vulnerable women secure jobs and sustain their well-being.

With US$22 million (725 million baht) from the UNDP, the Women and Wealth Project provides technical and marketing training in Cambodia, China and India. The idea is to help HIV-positive women live with dignity and economic independence.

HIV-positive women are encouraged to work together to form small business enterprises to support themselves and their families.

In principle, the programme allows HIV-positive people and family members not infected by the virus to work together. It also creates better understanding of Aids in communities and reduces the social stigma of the virus.

"In a rapidly feminising epidemic, the socio-economic independence of women is essential. It enables women to cope with the devastating impact of the epidemic on their families and livelihood. Useful skills and regular income can reduce HIV vulnerability and help positive women live with dignity and security," said Catilin Wiesen, HIV team leader at the UNDP Regional Centre in Colombo.

Gender inequality and stigma are critical problems for HIV-positive women and girls in the region. This was highlighted during the International Congress on Aids in Asia and the Pacific held recently in the Sri Lankan capital.

Most married women contract the virus from their husbands. When the breadwinners die, women have difficulty achieving economic security and finding resources to run businesses and support their children. Some are forced to turn to the sex industry to survive.

Mechai Viravaidya, chairman of PDA, said access to credit is a human right, and it is also the right of women living with HIV to be economically secure and independent.

"With economic empowerment and business skills, they can overcome the barriers associated with Aids," he said.

"As I have often said, to combat the issue of HIV, we must all think outside of the box."

Srim Phan and her group opened a garment manufacturing business in Phnom Penh called the Modern Dress Manufacturing Factory.

In Chennai, India, an HIV-positive women's network has established a conceptual design and printing business called Social Light Communications. It employs two HIV-positive women and two men as partners.

Another group of HIV-infected women in Yunnan, China has set up a factory to make candles from bee's wax.

"This project is a demonstration that we can be economically independent if given a level playing field and a little support," said Srim Phan, 27, who is the firm's manager.

She said members earn about $45 (1,500 baht) a month from the export of clothing products to Japan and the US. "It's not that much, but at least we have some money to send our kids to school."

Apart from economic security, the well-being of women living with Aids is also ensured. Members of the project's garment factories in Cambodia receive anti-retroviral drugs.

It isn't easy to gain access to new markets, but she remains optimistic the group will get support from within the industry to sustain the business.

P. Kousalya, service manager of the hand-made card printing firm in Chennai, said: "We are not looking for charity, but partnerships for empowerment. If we can access even a fraction of the market, it can make a big difference to our lives."

The card business can generate up to $125 (4,100 baht) a month for each member to support their families.

She is looking forward to breaking even and paying back money to the loan scheme. Net profits will also soon be pooled into the micro-credit programme for other HIV-positive women.

"The job makes us feel alive and gives us hope for tomorrow. It also gives us the power to survive and to live for ourselves and families," she said.

Drug licensing plan averted by donor offer: Swiss company will give drugs to Thais  - August 25, 2007

The Public Health Ministry has cancelled its plan to issue a compulsory licence (CL) for the production of a leukaemia drug after the Switzerland-based manufacturer promised to donate the drug to meet the demands of all Thai patients. However, it will not go back on compulsory licensing on other drugs, despite pressure from the US and the European Union.

The government has insisted the licences will save lives and that all CL moves will be considered carefully.

Vichai Chokevivat, a public health specialist chairing a committee looking into the government's CL policy, said yesterday that Novartis International AG told Public Health Minister Mongkol Na Songkhla that it would donate imatinib, under the Glivec brand, to meet demands of patients with chronic myeloid leukaemia (CML).

Earlier, Dr Vichai said the Public Health Ministry had planned to impose CL for the drug because most CML patients could not afford the treatment.

He also met representatives of the Food and Drug Administration, the ministries of foreign affairs, labour, commerce and sciences as well as Aids activists to discuss a recent written request from the US for Thailand to stop issuing compulsory licences.

The letter, dated July 20, was submitted to Prime Minister Surayud Chulanont by US ambassador Ralph Boyce.

According to Dr Vichai, the meeting resolved that the CL policy would continue because the government has a duty to ensure people have affordable access to medicine for treatment of serious diseases.

CLs are in line with the Agreement on Trade Related Aspects of Intellectual Property Rights (Trips) and the Doha Declaration which permits flexibility on patent rights for the sake of public health regardless of trade interests, he said.

Thailand says it will implement CLs only to save people's lives and not to reap commercial benefits, Dr Vichai added, arguing that some developed nations had issued more CLs than developing ones. "The US itself has widely issued CLs," he said.

He said the government was studying a proposal by Gilead Sciences Co that offered to charge a low royalty fee for production of the tenofovir antiretroviral drug for HIV-infected people who were also narcotic drug users and had hepatitis C.

He would pass on the meeting's conclusions to the public health minister and the prime minister.

Jon Ungpakorn of the Aids Access Foundation, who attended yesterday's meeting, said the government's stance was in line with international practice and was based on morality. CLs will save patients' lives because drugs will be more widely available to them, he said.

The death rate of Aids patients has dropped by 80% in the past five years thanks to availability of non-patented drugs but they now need patented and expensive drugs to cope with refractory illnesses, Mr Jon said.

Govt buys heart drug from India: Compulsory licensing praised at UN forum - August 23, 2007

The Public Health Ministry has decided to import a generic version of the heart drug Plavix from India under compulsory licensing, a policy praised by a United Nations agency and health advocacy groups as an example for other countries to follow.

The first shipment of two million tablets of clopidogrel is expected in two months, Government Pharmaceutical Organisation (GPO) board chairman Vichai Chokvivat said yesterday.

The heart drug will be supplied by the Indian company M-cure, which entered the lowest of four bids, at 1.01 baht per tablet. The price compares with 70 baht a tablet for the patented drug available on the market.

The ministry has already issued compulsory licences for two key Aids drugs, Efavirenz and Kaletra. It has already begun importing cheaper versions of Efavirenz from India, a major source of generic drugs.

The ministry has justified breaking the patents for the drugs, held by Western pharmaceutical companies, by citing budget constraints in providing advanced medication for people living with HIV/Aids under the universal health scheme, which covers 80% of Thailand's 63-million population.

Abbott Laboratories holds the patent for Kaletra while Efavirenz is patented by MSD, and Plavix by Sanofi Aventis.

"The GPO will import the medicine and ask the firm to register with the Food and Drug Administration as soon as possible," Dr Vichai said. "We will buy two million tablets in the first order and the shipment is expected to arrive in a month or two."

The ministry would save about 138 million baht, he said.

An estimated 20.5 million tablets of Plavix are needed for heart disease patients under the universal health scheme.

Only 20% of patients currently have access to the medication.

The compulsory licensing policy was hailed yesterday by non-government organisations and a UN agency.

But it was criticised by the United States, the European Union and drug manufacturers, which accused the government of stealing intellectual property and question its spending priorities.

The Eighth International Congress on Aids in Asia and the Pacific, being held in Colombo, Sri Lanka, was told Thailand's decision to run with compulsory licensing was one of the most critical political commitments yet to combat Aids. It was a good example for other countries in Asia and the Pacific heavily affected by the epidemic to follow.

"Thailand has made a strong statement by invoking a compulsory licence for the production of second-line antiretroviral drugs.

"It's the right thing to do because we just can't provide those who need with only the first-line drugs because of the high cost," said Prasada Rao, director of the UNAids regional support team.

"I urge countries in Asia and the Pacific region to use the WTO [World Trade Organisation] flexibilities to do more and show more commitment to Aids responses," he told the more than 2,500 participants at the meeting.

The 70 member countries will address the issue in the Colombo Declaration, to be released today at the end of the five-day conference.

The Asia Pacific Network of People Living with HIV/Aids has already released a statement calling on other governments, the UN and other organisations to provide access to antiretroviral drugs, including second-line treatment and other essential medicines, via the Trade Related Aspects on Intellectual Property Rights agreement. It said these were fundamental needs.

It also supported the compulsory licensing policy implemented in Thailand and strongly opposed any free trade agreements which would jeopardise the rights of both HIV-positive people and developing countries to have access to affordable medicine.

Health and consumer groups yesterday condemned US ambassador Ralph Boyce and the European Union's trade commissioner Peter Mandelson for protesting against the decision.

The groups included the Thai Network of People Living with HIV/Aids, the Aids Access Foundation, Oxfam and Medecins Sans Frontieres. Jiraporn Limpananont, president of the Consumers Foundation, said the protest letters were an unwarranted intervention in Thailand's health policy to ensure proper access to health care and treatment.

EMPOWERING THE VULNERABLE - August  2007

A UN-backed project is helping HIV-positive women retain their independence through micro-credit schemes.

As an HIV-positive widow in Cambodia, Srim Phan had no hope.

That was until she was encouraged to form a group, take a loan from a micro-credit scheme and start a sewing factory.

Her life has since changed for the better, she said.

The scheme is modelled on a critically acclaimed programme known as the Positive Partnership Project, launched in Thailand by the Population and Community Development Association (PDA).

In 2006, the United Nations Development Programme (UNDP) used the PDA as a model for a pilot project to economically empower HIV-positive women. It helps the vulnerable women secure jobs and sustain their well-being.

With US$22 million (725 million baht) from the UNDP, the Women and Wealth Project provides technical and marketing training in Cambodia, China and India. The idea is to help HIV-positive women live with dignity and economic independence.

HIV-positive women are encouraged to work together to form small business enterprises to support themselves and their families.

In principle, the programme allows HIV-positive people and family members not infected by the virus to work together. It also creates better understanding of Aids in communities and reduces the social stigma of the virus.

"In a rapidly feminising epidemic, the socio-economic independence of women is essential. It enables women to cope with the devastating impact of the epidemic on their families and livelihood. Useful skills and regular income can reduce HIV vulnerability and help positive women live with dignity and security," said Catilin Wiesen, HIV team leader at the UNDP Regional Centre in Colombo.

Gender inequality and stigma are critical problems for HIV-positive women and girls in the region. This was highlighted during the International Congress on Aids in Asia and the Pacific held recently in the Sri Lankan capital.

Most married women contract the virus from their husbands. When the breadwinners die, women have difficulty achieving economic security and finding resources to run businesses and support their children. Some are forced to turn to the sex industry to survive.

Mechai Viravaidya, chairman of PDA, said access to credit is a human right, and it is also the right of women living with HIV to be economically secure and independent.

"With economic empowerment and business skills, they can overcome the barriers associated with Aids," he said.

"As I have often said, to combat the issue of HIV, we must all think outside of the box."

Srim Phan and her group opened a garment manufacturing business in Phnom Penh called the Modern Dress Manufacturing Factory.

In Chennai, India, an HIV-positive women's network has established a conceptual design and printing business called Social Light Communications. It employs two HIV-positive women and two men as partners.

Another group of HIV-infected women in Yunnan, China has set up a factory to make candles from bee's wax.

"This project is a demonstration that we can be economically independent if given a level playing field and a little support," said Srim Phan, 27, who is the firm's manager.

She said members earn about $45 (1,500 baht) a month from the export of clothing products to Japan and the US. "It's not that much, but at least we have some money to send our kids to school."

Apart from economic security, the well-being of women living with Aids is also ensured. Members of the project's garment factories in Cambodia receive anti-retroviral drugs.

It isn't easy to gain access to new markets, but she remains optimistic the group will get support from within the industry to sustain the business.

P. Kousalya, service manager of the hand-made card printing firm in Chennai, said: "We are not looking for charity, but partnerships for empowerment. If we can access even a fraction of the market, it can make a big difference to our lives."

The card business can generate up to $125 (4,100 baht) a month for each member to support their families.

She is looking forward to breaking even and paying back money to the loan scheme. Net profits will also soon be pooled into the micro-credit programme for other HIV-positive women.

"The job makes us feel alive and gives us hope for tomorrow. It also gives us the power to survive and to live for ourselves and families," she said.

Amorous Thais rush to condom tests  - August 22, 2007

BANGKOK - Some 1,000 amorous Thais have applied for 500 positions to volunteer to test condoms for customer satisfaction, a firm said Wednesday, as part of a campaign promoting safe sex.

"We are surprised to see huge interest in our campaign with almost 1,000 applicants wanting to take part," said an official at a Thai marketing firm for condom-maker Durex.

The campaign was part of Durex's efforts to promote safe sex as well as giving Thais "an outstanding opportunity to enjoy their favorite pastime," Durex said in a statement.

Condom volunteers must be Thais aged over 20 years old, it said, adding that "no educational qualifications are necessary."

Successful applicants will receive free Durex tester kits and be required to respond to an online questionnaire following each use.

The Thai government has said HIV/AIDS is the kingdom's top cause of death, followed by heart disease. Some 500,000 Thais are infected with HIV.


UN warns of Thai housewife HIV/Aids crisis: Sharp rise in infection rate prompts con - August 21, 2007

Sri Lanka - International Aids campaigners have raised concern over a sharp increase in infections among Thai housewives, fearing the rise of new cases in this formerly low-risk group reflected the country's complacency in tackling the epidemic.

Deborah Landey, deputy executive director of the Joint United Nations Programme on HIV/Aids (UNAids), said the soaring infection rate among housewives was alarming and intervention programmes needed to be urgently scaled up to curb the spread.

She was speaking at the opening of the eighth International Congress on Aids in Asia and the Pacific held in Colombo.

The Aids epidemic is constantly changing, she said, and it's important to know the current situation so effective HIV prevention and treatment campaigns can be tailored to help those in need.

In Thailand, up to 40% of the 18,000 new cases found each year are housewives, which was previously identified as a low-risk group.

Most housewives contract the virus from their promiscuous husbands who have had casual sex.

The number was high compared to so-called high-risk groups, such as men having sex with men (28%) and sex workers (10%).

In response, Public Health Minister Mongkol na Songkhla plans to promote a "family condom" campaign to encourage married couples to stay monogamous.

An estimated 580,000 adults and children in Thailand were living with HIV at the end of 2005, according to UNAids.

In the region, Ms Landey said, the situation has worsened in Papua New Guinea, where half of new Aids cases are housewives. Housewives also account for at least 46% of all new cases in Cambodia, she said.

Ms Landey called on policymakers of countries in the region to increase funding to the fight against Aids, especially among innocent and vulnerable groups like housewives and marginalised people.

Myung Hwan Cho, president of Aids Society Asia Pacific, said the Aids response in the region was inadequate. The region can expect 12 million new Aids cases by 2010 unless immediate action is taken and cooperation between policymakers, the public and the private sectors is strengthened.

The latest statistics show one-fifth of the Asian population is HIV-positive.

"We now need not only more condoms, but also more treatment and different approaches to combat Aids in the region. Better action is needed because we're still a long way behind the epidemic," said Sri Lankan President Mahinda Rajapaksa.

He called on governments in Asia to join hands with the public and private sectors, particularly manufacturers and marketers of Aids drugs, to ensure drugs are available to all at affordable prices.

"The threat to the well-being of humanity posed by HIV/Aids is such that it is necessary to rethink established policies with regard to patents and ownership of essential drugs, and think in terms of more liberal policies that are based on the needs of the people," he said.

Sri Lanka has one of the lowest infection rates in the world, with an estimated 5,000 people living with HIV.

However, the president said, the figure did not reflect the risk across Asia, and vigilance against infection in the world's most populous region had to remain constant.

US envoy asks PM to help solve patent row  - August 18, 2007


The US ambassador to Thailand has asked Prime Minister Surayud Chulanont to intervene in the Public Health Ministry's compulsory licensing policy. Ralph Boyce said in his letter dated July 20 he was afraid that the faded compulsory licensing issue might re-emerge since "the Health Ministry was actively considering a list of additional drugs for compulsory licensing."

"The US government thinks it is important for all countries, including Thailand, to play a role in, and benefit fully from, the development of new and more advanced medical treatments. Strong protection of intellectual property rights, including patents, remains a vital part of that process," said Mr Boyce.

The ambassador noted that while all World Trade Organisation (WTO) members have the ability to make appropriate use of flexibilities to address urgent situations, these decisions should not be made lightly and only as a last resort.

Surapong Jayanama, secretary to the prime minister, early last month asked the Health Ministry's permanent secretary to consult with other agencies concerned, including the ministries of foreign affairs and commerce, to find common ground on the matter.

The Public Health Ministry will hold a meeting next week with other stakeholders, including HIV/Aids patients, networks of heart disease and cancer patients, as well as the Labour Ministry and Social Security Office.

The US envoy's concern followed a controversial letter from European Union trade commissioner Peter Mandelson to his counterpart Krirk-krai Jirapaet, as well as Foreign Minister Nitya Pibulsonggram and Health Minister Mongkol Na Songkhla, protesting against Thailand's consideration of the broad use of compulsory licensing.

Expert warns of risks of bogus medication - August 9, 2007

A health expert has warned of the dangers of counterfeit erectile dysfunction and malaria drugs that have flooded local markets and neighbouring countries. Praphon Angtrakul, a pharmacist at the Food and Drug Administration, said the fake drugs were undermining Thailand's efforts to promote good manufacturing practices among domestic pharmaceutical producers.

"This problem should be seriously addressed because it tarnishes the country's image and drug manufacturing standards, especially when Thailand is still under the Priority Watch List of the US Trade and Representatives in which intellectual property rights are very much involved," he said at a meeting on good manufacturing practices yesterday.

Fake pharmaceutical medicines can often contain dangerous or ineffective substances that can cause illness, injury and even death.

Mr Praphon said that in Thailand, most erectile dysfunction medication, malaria and tuberculosis drugs heavily marketed via the internet are fakes. Some are sent through courier services, the general mail or are on shop shelves.

"Pharmaceutical sales in Thailand are worth about 80 billion baht [a year]. But the fake drugs trade can generate higher profits," he said.

The FDA official also said the World Health Organisation (WHO) recently inspected the Cambodian pharmaceuticals market and reported that most of the counterfeit drugs, including antibiotics, penicillin, paracetamol and vitamin C tablets, were produced by illegal factories in Thailand that were already shut down.

The FDA is in the process of investigating if any registered pharmaceutical firms were involved in the production of fake drugs.

However, it is not just Thailand that is suffering the effects of fake drugs. Reports of the problem are increasing rapidly around the world, especially among developing countries. In Asia and Latin America for example, counterfeit sales account for 30% of the market, according to the WHO.

FDA secretary-general Siriwat Thiptaradol said checkpoints have been set up along border provinces to try and stem the trafficking of fake drugs.

But he conceded that counterfeit malaria, Aids, tuberculosis and bird flu drugs were a big problem, not only in Thailand but also in other developing countries.

Dr Siriwat said counterfeit drugs often had extremely varied compositions. Some contain totally inert substances like starch while others are made of cheap materials like paracetamol, he said.

"The poor could become victims of fake drugs that lead to health risks and can eventually cause death," he said.

Most fake products found in developed countries include steroids, hormones and allergy drugs, he said. India and China are known to be major bases of counterfeit drug manufacturing and trafficking, he added.

The International Narcotics Control Board, the Vienna-based drugs watchdog, last March released a report on lethal fake drugs worldwide, urging the UN and WHO to help member states which may not have sufficient resources to tackle the problem.

PETITION

ABBOTT: STOP THE INTIMIDATION! WE WILL NOT BE SILENCED!

Global AIDS community expresses solidarity with Thailand and ACT UP­Paris. And urge Abbott to immediately drop the charges against the AIDS organization

On May 23rd Abbott Laboratories, manufacturers of the anti­retroviral drugs Norvir and Kaletra, became the first pharmaceutical company to intentionally attempt to cause the demise of an HIV/AIDS community group by filing a lawsuit in French criminal court against ACT UP­Paris. Abbott claims ACT UP­Paris’ April website “zap” shut down its server for a few hours prior to its annual shareholders meeting.

French law forbids the limiting of access to a website, unless a defendant has a “legitimate motive”. Holding Abbott accountable for unethical business conduct and highlighting Abbott’s denial of essential medicines can surely be interpreted as a legitimate and honorable motive.

A Paris judge has scheduled an Oct. 26 hearing in criminal court. If ACT UP Paris loses the criminal case, French law proscribes a maximum fine of €75,000, or $100,000 and/or the disbanding of the AIDS organization. Either option will result in the closure of ACT UP­Paris.

HIV patients, doctors and their organizations have scorned Abbott for many years as a result of excessive prices charged for its HIV drugs and for the 400% price increase of its monopoly boosting drug, Norvir, in the United States. The company is now divesting from HIV research and remains only interested in maximizing returns from its existing HIV products.

In recent months, the company has been embroiled in a standoff over access to its drug Kaletra in Thailand. ACT UP­Paris was among the many AIDS activist groups globally that joined an International Day of Action on April 26, 2007, to protest against the company’s withdrawal of applications for new life­saving drugs in Thailand.

Earlier this year, Thailand stated that it could not afford Abbott’s price for Kaletra. The Thai government announced that it planned to use compulsory license provisions, pursuant to international trade law, that allows countries to procure cheaper generic versions of a patented drug in health emergencies. By utilizing compulsory license provisions, the Thai government would save millions of dollars that could be used for life­saving medications for its citizens.

Abbott countered by announcing that it would not register any newly developed drugs in Thailand, depriving that country of the new form of Kaletra that, in contrast to the current form, does not require refrigeration, an obvious issue in tropical Thailand. Despite the fact that the compulsory licenses for Kaletra were legally issued by the Thai government in accordance with WTO TRIPS provisions, Abbott announced that it would refuse access of its new heat­stable version of Kaletra to the 220.000 HIV patients in Thailand.

The World Health Organization, doctors and community organizations globally have called upon Abbott to reexamine its position. The French and British governments publicly supported the Thai government’s right to issue the compulsory drug licenses. People living with HIV/AIDS in Thailand have pleaded with Abbott to reverse its decision and called upon the international community to show solidarity with their cause. ACT UP­Paris responded to their call with the alleged criminal “action”.

Phone and fax zaps or sit­ins, which have disrupted corporate communication for short periods of time, or blocked employee work access, are not new to AIDS activism. These tactics have been used by many other activists throughout the many years of the long epidemic to draw attention to government or corporate acts and omissions.

Such community “actions” in the past have been responded to by government and industry by initiating direct meetings to discuss options and solutions to very real problems and concerns. This has lead to regularly meeting with the community, who represent, and in many instances who are the actual consumers of the products generated by industry and government. This process has led to practices that are mutually beneficial to all stakeholders – expedited and ethical drug development and research, resulting in greater profits for industry and the dramatic extension of life and quality of life of people with HIV/AIDS.

We believe Abbott’s aggressive legal moves are disproportionate and misguided. We call on Abbott to immediately withdraw its lawsuit, to meet with ACT UP­Paris and agree to change its current hostile policies and practices. If Abbott continues to bully ACT UP­Paris and patients internationally, AIDS organizations will have no choice but to continue to engage in such “actions” and to inform all stakeholders of the unethical practices implemented by Abbott Laboratories.

The undersigned organizations stand firm in their solidarity with the Thai HIV community and ACT UP­Paris. We welcome this opportunity to debate Abbott’s shameful policies in Thailand and elsewhere. Regardless of Abbott’s decision on the case against ACT UP­Paris, we will not be intimidated and we will continue to do everything in our power to convince the company to reverse its unprecedented decisions to stifle freedom of speech and deprive the Thai people of life­saving medications.

AIDES, France AIDS ACCESS Foundation, Thailand AIDS Treatment Activists Coalition (ATAC), USA ARCI­Gay, Italia Community HIV/AIDS Mobilization Project (CHAMP), USA European AIDS Treatment Group (EATG), Belgium European Network of People Living with HIV/AIDS (ENP+), The Netherlands Global AIDS Alliance, USA Global Network of People Living with HIV/AIDS (GNP+), The Netherlands Health GAP (Global Access Project), USA International Community of Women Living with HIV/AIDS (ICW) LILA, Italia SIDACTION, France Thai Network of People Living with HIV/AIDS (TNP+), Thailand.

We need your help! More organizational endorsements will send a clear message to Abbott. If your organization can lend its support to this effort by endorsing this sign-on action, please send an e-mail to petition.abbott@gmail.com with the name and country of your organization. This letter is for organizational sign-ons, we are not collecting the signatures of individuals for the moment. We do encourage all organizations to sign, even if they are part of a larger coalition that has already signed.

Thank you for your support!

Final phase of Aids vaccine trial extended: Researchers uncertain about effectiveness  - July 31, 2007


The final phase of an Aids vaccine trial in Thailand will be extended for another two years as researchers are not certain if the vaccine is actually effective.

Chief researcher Supachai Rerksngarm said his team needed to extend the research until 2009 before concluding whether the vaccine was effective and could be produced on an industrial scale.

"It's still too early to say if the vaccine is effective in terms of preventing people from Aids infection as the results that have emerged so far are not as effective as we expected," he said after a trip to the United States where he participated in the interim analysis with a team of vaccine experts last week.

The project received funding from pharmaceutical firms and health advocacy groups in the US along with the Thai Public Health Ministry.

The researchers' goal was to make the vaccine 80% effective after two years of research which began in October 2003. But the latest results showed only about 50-60% effectiveness, he said.

But Dr Supachai insisted the clinical trials were still following the plan, which is scheduled to end in July 2009.

A stumbling block in the project primarily involved the shortage of volunteers as it took a long time before all 16,000 people in the provinces of Chon Buri and Rayong were recruited as planned.

Each volunteer was given either a vaccine or a placebo over a one-year period and followed up after at least three and a half years.

The so-called prime-boost test combines two vaccines-Alvac, which was created by France-based Aventis Pasteur, and AidVAX B/E, made by the California based VaxGen Inc, to stimulate different immune response systems simultaneously. The trial in Thailand was the first time the two vaccines were combined as experts believed the combination was an effective alternative to HIV/Aids control. Previously, research projects in Africa had used only one vaccine at a time and the results were not satisfactory.

However, some researchers have questioned the vaccine's validity, and the scientific ethics and efficacy of the trial.

A group of 22 prominent Aids researchers in 2004 wrote in the journal Science that the trials should be halted because of the high cost and because the two vaccines used in the Phase I and Phase II clinical trials were ineffective in preventing HIV transmission.

But Dr Supachai remained positive about the trials, saying the combination vaccine showed promising results. Efficacy of the earlier vaccine trial among sex workers in Bangkok was about 30% compared to the AidVAX trial at 50%.

In order to produce the vaccine on an industrial scale, the efficacy level should be no lower than 50%.

According to the deal with the pharmaceutical firms participating in the project, volunteers getting the placebo would receive the vaccine for free if the trial proved successful. In addition, the firms had to provide three million Aids vaccine doses for Chon Buri and Rayong residents within five years, he said.

Unreasonable fear of HIV - July 31, 2007

Ignorance is the major factor behind the shocking treatment of those known to have tested positive for HIV/Aids.

Twenty years after the outbreak of Aids in humans panicked the world, and 10 years after experts confidently predicted a vaccine, science has produced neither an immunization nor a cure. There have been important advances, based on medical knowledge. Many people who contract the Aids-causing HIV, today have a good chance of being able to co-exist with the disease and live a somewhat normal lifespan.

The poor still face huge barriers before they can obtain life giving medical care. But the biggest problem has become the ignorance and the discrimination of those without Aids against those with the disease.

A group supported by the United Nations has launched a serious, pan-Asian effort to fight this problem. The Independent Commission on Aids in Asia and the Pacific might have come up with a catchier name. Nevertheless, the group has kicked off a programme to educate the public and boost the chances of HIV/Aids victims. It will be funded by UNAids, but the commission is independent and can apply local tactics to counter bias in communities across our continent.

This is an effort that is long overdue. Ever since the outbreak of Aids in the mid-1980s, victims have had to withstand rampant discrimination. In many ways, Aids has become the new-age leprosy, where those with the disease are locked away from society. This is not only a figure of speech. Around the world and right here at home in Thailand, seemingly intelligent people refuse to approach Aids victims, force them to move from their neighbourhoods, and even discriminate against their families and children - who frequently are barred from schools.

But while the discrimination is both shameful and scandalous, there must be a huge question of whether yet another committee is the way to approach the problem. The stigma placed on HIV/Aids victims and their families seldom originates from government at all. The problems described by those who are diagnosed as HIV-positive now have a familiar ring. Employers invent ways to fire them. Neighbours pressure schools to ban the children. More than 12 years after legislation barred Thai businesses and civil servants from separating HIV/Aids patients, the discrimination continues at a local level. Ignorance is undoubtedly the major factor behind the shocking treatment of those known to have tested positive for HIV/Aids. Many people still have the idea that the virus can spread through the air, or simply by a touch.

Chakravarthi Rangarajan, the Indian who chairs the Independent Commission, has encouraged a series of meetings with government officials and representatives of civil society in the Philippines, Bangladesh, China and so on. The chief accomplishment after almost a year is the conclusion that governments lack what the Commission calls "an urgency of response." This is hardly newsworthy; it is something any reasonably aware person could have easily reported even before the meetings.

What is needed, and what will earn the commission quick recognition and public support, is action. Example: The Population and Community Development Association has been providing micro-loans to Thais diagnosed with HIV/Aids to setup small businesses; it could use support and funds. Example: Bangkok businesses including tourist facilities openly discriminate against HIV/Aids victims; their owners and managers badly need serious education about a problem they obviously misunderstand.

The drive to end discrimination against HIV/Aids sufferers must also go hand in hand with medical treatment. The campaign by Public Health Minister Mongkol Na Songkhla to reduce the price of high-technology medicine that allows HIV/Aids patients to live a reasonably normal life is because the drugs are needed for life. Such drugs must be affordable. There must also be a renewed campaign and law enforcement to educate the public about HIV/Aids. The shameful discrimination should stop. This should be the aim of the Commission.

Safe-Sex Campaign: Thai girls rarely carry condoms  - July 28, 2007
 

Kittaya Jantarataneevivat, 16, giggled as she grabbed a condom from a volunteer distributor while strolling in front of a department store in the Ratchaprasong area yesterday.

The girl, a student of Surasak Montri School, was among many young people, both boys and girls, who received free condoms in a campaign to promote safe sex by the Public Health Ministry in the city's main shopping district.

The schoolgirl carefully looked at the small package, squeezing it lightly while giggling.

When approached by the Bangkok Post a minute later for a comment, she immediately said she didn't want to talk about it.

"Yes... I know what it is. My mother often discusses sexual diseases and how to prevent them with me," she said.

Have you ever used one?

"No!"

Have you ever bought one?

"Absolutely not!" she replied, with a blush.

Even though girls in Thailand are now more open to sexual issues, they are still quite conservative when it comes to the subject of condoms.

Unlike boys, girls risk being labelled as "bad girls" if they show they are too keen on this taboo subject.

According to a survey by the Public Health Ministry, Thai girls hardly carry condoms and are also too shy to ask their partners to use them.

The ministry's survey last year showed that of 80% of teenage girls who admitted to having had sex, only half said their male partners had used condoms, while 47% of teenage boys said they always carry condoms. The survey also showed that women, particularly young girls, are two times more likely to get Aids compared to men.

The Public Health Ministry said a change is needed to this reserved attitude among women.

In western countries, girls are more comfortable about asking their partners to wear condoms or even saying "no" if their men refuse to use them.

Public Health Minister Mongkol Na Songkhla said he hopes the campaign will change the attitude of Thai teens and adults alike.

"I wish Thai society had a positive attitude to condoms, just like when we use separate spoons when eating with others to prevent the transmission of diseases," he said. The ministry's safe-sex campaign will continue in the major provinces until the end of the year.

Thailand to broaden patent breaking policy: Will cover all state healthcare schemes - july 26, 2007

Thailand is pressing ahead with its policy on compulsory licensing (CL) with a plan to expand the policy to cover all state healthcare programmes, enabling more people to access affordable life-saving drugs. The plan, initiated by scholar-economist Ammar Siamwalla, was endorsed by the National Health Security Office board yesterday.

Currently, the CL policy on three important drugs for Aids and heart treatment - Efavirenz, Kaletra and Plavix - is basically limited to patients under the universal healthcare scheme run by the National Health Security Office (NHSO).

Better known as the 30-baht healthcare scheme, it covers some 48 million people, mostly children, the poor, the elderly and the unemployed. Some of the patients who are civil servants, with approval from their physicians on a case-by-case basis, also benefit from the policy. Left out from the policy are office workers and labourers who are under the healthcare programme run by the Social Security Office (SSO).

Under the plan, the CL policy will in principle cover all three schemes, said NHSO secretary-general Sa-nguan Nittayarumphong.

At the same time, he said, a sub-committee on CL has been set up to consider a group of essential drugs which CL should be further applied to. The panel comprises academics, health experts and representatives from relevant state agencies such as the SSO, the Commerce and Foreign ministries, the Comptroller-General's Department, and the Budget Bureau.

The Comptroller-General's Office is responsible for the healthcare budget for civil servants whereas the SSO manages the healthcare fund for workers and employees of private firms.

Dr Sa-nguan, who chairs the sub-committee, believes patients under the SSO-run healthcare scheme should also benefit from this state policy.

He also pointed out that the new drug list for the CL policy has yet to be finalised.

So far, the subpanel has studied the possibility of enforcing CL on two cancer drugs, whose names have not been officially disclosed. But Dr Sa-nguan said all drugs listed for CL would be distributed to all healthcare schemes.

Saengsuree Joota, a doctor at Ramathibodi hospital and president of the Thai Society of Haematology, last week urged the government to be careful in announcing CL on a leukaemia drug with the trade name of "Glivec".

She feared that the policy would result in a disadvantage for some patients who already have access to the generic version of the drug.

At present, employees of private companies who suffer from leukaemia have no access to treatment due to the high cost of the drug. Also, the SSO only approves a healthcare fund for bone marrow transplants, which cost about 750,000-800,000 baht. A leukaemia patient will have to pay up to 1.5 million baht a year for treatment with the drug.

Mr Ammar urged health authorities to set up a system to manage and monitor drug distribution among state and private hospitals that provide medical services via the three healthcare schemes, to ensure that these drugs under the patent bypass would not be used for commercial benefit.

Kaletra Aids Medicine: Govt won't budge on breaking drug patent  - July 6, 2007

Thailand is sticking by its stance to override the patent of Abbott Laboratories' Aids drug Kaletra although Brazil has already agreed to buy the life-saving drug from the pharma giant. Health specialist Vichai Chokewiwat yesterday said the government would not accept Abbott's offer adopted by the Brazilian government.

"We understand that the Brazilian government has a reason to accept the deal. But we cannot do that. It's not the option we are hoping for," he said.

Dr Vichai, also chairman of the Government Pharmaceutical Organisation's (GPO) board, made his remark yesterday after Brazil Health Minister Jose Gomez Temporao accepted an offer from Abbott to cut the price of Kaletra by 30%.

The lower price for Kaletra, a combination of lopinavir and ritonavir, could save about $10 million a year for Brazil's Aids treatment programme, the minister said, and he urged other drug companies to follow suit by cutting prices.

Yesterday's landmark agreement was reached a month after President Luiz Inacio Lula da Silva issued compulsory licensing for the Aids drug to enable his government to import a cheaper generic version from India.

Dirk van Eeden, director of Abbott's HIV communication & policy department, told the Bangkok Post in a phone interview that an agreement with the Brazilian government should set a precedent for Thailand to review the company's offer.

To date, Thailand and Abbott have been unable to strike a deal on the price of Aluvia, a heat-stable version of Kaletra.

The ministry has asked the company to cut the Aluvia price to about 5% higher than that of the generic version.

But Abbott has insisted on selling the drug at 3,488.20 baht per person per month, or about 34,000 baht (US$1,000) per person per year, which the ministry said is still too expensive.

Public Health Minister Mongkol na Songkhla preferred the price quoted by India's generic drug maker, Matrix Laboratories, which sells a generic version of Aluvia at 2,027 baht per person per month, or 24,324 baht (US$695) per person per year.

In another development, the GPO is set to buy the first lot of two million tablets of the heart medicine chopidogrel, marketed as Plavix, from India for patients under the universal healthcare scheme.

He said the GPO has shortlisted four potential Indian drug manufacturers, but declined to name them.

The cost of the medicine ranges from between three and four baht per tablet and its price could increase to five to five-and-a-half baht per tablet including tax and transportation costs, he said.

"The patented version costs several times more than this," he said.

The original heart drug owned by Sanofi Aventis costs up to 90 baht per tablet.

In Thailand, it is estimated that five million tablets of the medicine are needed for patients suffering from heart disease each year.

The first batch of the drug is expected to arrive in Thailand around October, he said.

40% of new Aids cases are housewives  - July 5, 2007

The rising number of housewives contracting HIV/Aids from their husbands is a matter for serious concern, Public Health Minister Mongkol Na Songkhla said at a recent seminar. Aids activists are calling for a revival of campaigns promoting condom use to curb the growing infection rate.

Speaking during the 11th national seminar on Aids, Dr Mongkol said he was worried about the rising infection rate over the last two years, especially among married couples.

Up to 40% of the 18,000 new cases found each year were housewives. The number was relatively high compared to other risk groups such as men having sex with men, 28%, and sex workers, 10%. Most contracted the virus from their husbands who had casual sex.

Dr Mongkol said he was thinking of launching a "family condom" campaign as well as encouraging married couples to stay monogamous.

"Using condoms should be regarded as showing respect to each other so that both husband and wife will be safe from sexually-transmitted diseases such as HIV/Aids. Wives should also stand up for a better deal from their husbands," he said.

The national committee on Aids is working on the project with Mechai Viravaidya, widely known as Mr Condom. They will ask hotel operators to help by putting complimentary condoms in hotel rooms, he said.

Mr Mechai, who campaigned for condom use among sex workers when Thailand was first hit by the virus, urged the government to pay more attention to prevention programmes.

"Compulsory licensing is not the solution to Aids. It actually reflects the country's failure to promote a prevention campaign," he told the seminar.

Mr Mechai, chairman of the Population and Community Development Association, was appointed by the national committee on Aids to oversee a sub-panel to promote condom use.

Teenagers are regarded as a risk group as a recent survey showed about 67% of 6,000 respondents, aged 18-19, did not use condoms when having sex, he said.

Meanwhile, Democrat leader Abhisit Vejjajiva said Thailand should work closely with other Asean members when giving local drug manufacturers the right to copy drugs patented by big pharmaceutical firms

Thailand 'on course' to achieve UN development goals - July 3, 2007

Thailand is one of a small number of countries in the Asia-Pacific that is moving ahead to achieve the Millennium Development Goals (MDGs), Shigeru Muchida, deputy executive secretary of the UN Economic and Social Commission in Asia and the Pacific (Escap).

Thailand has been found to have fared outstandingly well in providing universal access to primary education and health care along with reducing poverty.

Countries that have made good progress include China, Vietnam and Azerbaijan, while India is among those catching up, said Mr Muchida, citing a mid-term review.

He called for help for the "off-track" group as well as those which are below other Asian averages to enable them to achieve the goals set at the UN General Assembly in 2000.

The MDGs include targets to be achieved by 2015 for UN members are to eradicate extreme poverty and hunger; achieve universal primary education; promote gender equality and empower women; reduce child mortality; improve maternal health; combat HIV/Aids, malaria and other diseases; ensure environmental sustainability; and develop a global partnership for development.

However, there are a number of challenges ahead, in particular the "disappointingly low" contribution of developed countries in allocating 0.7% of their gross national income to fund the MDG programmes.

"We need strong government leadership to make rapid large-scale progress on the MDGs, a continuous pro-poor economic strategy, full and fast delivery of developed countries' 0.7% of their gross national income on overseas development assistance (ODA), a successful and equitable conclusion of the Doha trade round, and for climate change challenges to be addressed," he said.

Erna Witoelar, UN special ambassador for the MDGs in Asia-Pacific, said there were only five "good donors" which had reached or exceeded the UN target of contributing 0.7% of gross national income for development aid.

The five are Denmark (0.81%), Luxembourg (0.82%), the Netherlands (0.82%), Norway (0.92%), and Sweden (0.94%). The statistics were from 2005.

The contribution of the US, the largest donor in term of the amount of the ODA (US$27.6 billion), accounted for just 0.22% of its gross national income, the third lowest of the OECD countries.

Ms Witoelar called for developed nations to live up to their promises. Besides, she said, aid should not be tied to political aims such as anti-terrorism or anti-nuclear programmes.

Reaching the MDGs was very important as it helped reduce social and security problems, she said, adding that advocacy nationally, regionally and internationally was therefore needed, especially from civil society, the media, the private sector and parliamentarians.

"If, by 2015, many countries cannot achieve the targets, the world will be in disarray with more natural disasters, poverty, political chaos and other forms of instability," said the ambassador.

However, she also called for national governments' commitment by investing in good governance.

"Funding is one thing, but good practice is also needed. It is very important [for governments] to eradicate corruption and install good governance to be able to deliver basic health services to the people," Ms Witoelar said.

Infected mums urged to take anti-viral meds  - June 26, 2007

The Public Health Ministry is stepping up its campaign for HIV-infected women to continue taking anti-viral drugs after giving birth.

It is the second stage of a five-year plan, lasting from 2004 to 2008, to provide care, protection and treatment for women during pregnancy and after giving birth, new-born babies and infected families.

Public health permanent secretary Prat Boonyawongvirote said the ministry's efforts to provide treatment to HIV-infected mothers have failed, as more than half of infected women stop seeing doctors after giving birth.

Discrimination by neighbours and health staff discouraged these women from seeking help.

He was speaking at a seminar with local administrative organisations, NGOs and networks of people with HIV/Aids to lay down guidelines for the care, protection and treatment of infected pregnant women.Deputy Health Minister Morakot Pornkasem said there are 7-8,000 new cases of pregnant women infected with HIV/Aids each year.

Without effective preventive measures to reduce the risk of mother-to-child transmission, the number of newborn babies infected with the virus could rise to 1,800 to 2,000 a year.

He said anti-viral drugs can reduce mother-to-child transmission to 6%.

The service will also be given to immigrant workers in 12 provinces - Samut Sakhon, Trat, Sa Kaeo, Si Sa Ket, Tak, Rayong, Ranong, Chiang Mai, Chiang Rai, Chachoengsao, Phetchaburi and Chanthaburi.

The programme is supported by the Global Fund, which aims to fight Aids, tuberculosis and malaria, with a budget of 560 million baht.

In the plan's first stage from 2004 to 2005, health staff were trained to take care of HIV-positive mothers after childbirth and infected family members.

HIV-positive people were urged to seek medical help at the 100 public and 724 community hospitals.

COMPULSORY LICENSING/PRIORITY WATCH LIST: Thailand is within its rights, say US reps  - June 22, 2007

Some members of the US House of Representatives have demanded the US Trade Representative (USTR) remove Thailand from the Special 310 Priority Watch List (PWL) and respect its right to issue compulsory licences for drugs. Republican representative from California Henry Waxman, in a letter on Wednesday signed by 34 congressional colleagues, told USTR ambassador Susan Schwab to reply by July 9 on their call for her office to reassess the policy.

The letter said Thailand's use of compulsory licensing to purchase generic versions of several drugs that were too costly for the government was a legitimate act within the international rights and obligations stated in the agreement on Trade-Related Aspects of Intellectual Property (Trips), under the World Trade Organisation (WTO).

"It is difficult to interpret the decision [to add Thailand to the PWL in the annual USTR trade report] as anything other than retaliation for Thailand's recent actions," said the letter.

The letter urged the USTR to reassess its policy towards Thailand to reflect the US commitment and respect for the rights of other nations to implement their intellectual property rules in a way that supports public health.

Being put on the PWL has led to the elimination of the duty-free access Thailand currently receives under the Generalised System of Preferences (GSP) for gold jewellery and other exports to the US. This will take effect on July 1.

The GSP cut penalises the legitimate exercise of the right to issue compulsory licensing, the congressmen said in the letter.

"We call on you to take steps to remove Thailand from the Special 301 Priority Watch List and abandon any further retaliation for Thailand's public health efforts, and ask you to commit to respecting the rights of WTO members to freely exercise public health flexibilities under the Trips and the Doha Declaration, including compulsory licensing," they added.

The compulsory licences Thailand issued were for non-commercial government use and therefore Thailand was under no obligation to consult with the patent holders, they said.

The licences are for Aids and heart disease medications.

Washington-based Essential Action, a non-governmental organisation, backed the move by the US lawmakers.

The letter by the 35 congressmen reflected growing sentiment in congress that US policy on access to medicines must change, its director, Robert Weissman, said in a statement.

"By using legal methods to authorise price-lowering generic competition on overpriced Aids and heart-disease drugs, Thailand has shown the world what it means to place public health over commercial considerations," he said.

Essential Action agreed with the lawmakers that the USTR had put Thailand on the priority watch list to retaliate for the decision to use compulsory licensing.

"USTR's retaliatory placement of Thailand on the priority watch list was designed to punish the country for prioritising public health over the interests of Big Pharma [large pharmaceutical companies]," he said.

The trade measure was designed to send a message to other developing countries that they will be punished for issuing compulsory licences and utilising the public health flexibilities available in the WTO rules, he said.

Call for tax revenues to fund drug R&D: 'Way to raise medicine access' in poor nations - June 19, 2007

A leading health activist has urged developing nations to consider using tax revenues to support research and development on essential drugs for the public, as an option for expanding access to medicine and avoiding patent disputes.

Jon Ungpakorn proposed the idea during a seminar on compulsory licensing at Thammasat University's economics faculty. He said it would help developing countries invent important generic drugs without having to face restrictions placed by patent holders in rich nations.

"As long as the issue of drug prices comes before the life and death of individuals, this kind of system will be initiated sooner or later as the unjust patent system happens the world over," he said. The funding for public-oriented research and development on drugs could be based on gross domestic product per capita, he added.

The HIV/Aids epidemic is an example which highlights the problem of drug access, since many young adults in low and middle income countries have the virus but price barriers deprive them of access to treatment.

In Thailand, for example, Aids deaths had surged from 8,000 in 1999 to 1,600 in 2006 after the country successfully introduced the locally-produced anti-retroviral treatment GPO-Vir and provided HIV-positive people with free treatment via the universal healthcare scheme, Mr Jon said.

The Magsaysay award-winner also believes the issuance of compulsory licensing in developing countries would become "normal" in the near future since the patent system has restricted access to medicines for the majority of the world's population.

"Developing nations should work together to seek ways to cope with increasing restrictions on essential drugs and other medical instruments necessary to treat other neglected ailments such as malaria and TB, which have been on the rise in the past few years," he said.

The Thai government issued compulsory licensing under the agreement on Trade-Related Aspects on Intellectual Property Rights (Trips) to bypass patents on the anti-Aids and heart drugs Efavirenz, Kaletra and Plavix last November and January.

The move upset big pharmaceutical firms holding the patents for those drugs. Negotiations on cheaper prices are still underway between the Public Health Ministry and the pharmaceutical firms.

Mr Jon said the Network of People Living With HIV/Aids was keeping an eye on the talks between the state and the private sector and would push the present government to make the final decision on whether it will import drugs from generic makers in India or continue to buy original drugs next month, since the stockpiles of these drugs would run out in August.

However, the state policy on compulsory licensing has sparked concerns in the business sector over the possible withdrawal of hundreds of Thai export products from the US Generalised System of Preferences (GSP) list after the US reviews the list on July 1.

But Suthichai Iamcharoenying, chairman of the Social Venture Network Asia (Thailand), representing a group of private entrepreneurs, believed an estimated five billion baht GSP tax waiver was not as important as the lives of more than 6,000 HIV-positive people which could be saved due to the state policy on free Aids treatment and compulsory licensing.

Negotiations on drug prices hit deadlock: Govt to go ahead with compulsory licensing  - June 7, 2007

A meeting to negotiate drug prices between the Food and Drug Administration (FDA) and two pharmaceutical firms remained deadlocked yesterday as the Public Health Ministry confirmed that it would go ahead with its plan for compulsory licensing. Abbott Laboratories and Sanofi Aventis stood by their previous price list, while the FDA wanted them to lower the prices to 5% above that for the generic version of the same drugs.

Abbott is sticking by its price for the heat-stable version of an Aids drug called Aluvia at $1,000 (33,000 baht) per person per year, on condition that the ministry revokes compulsory licensing of its second-line anti-retroviral treatment.

Sanofi Aventis also kept the price of Plavix at 27 baht per tablet for patients receiving treatment under the Social Security Office and the universal healthcare schemes.

"If there is no satisfactory agreement on prices, the ministry may have to make a decision to buy drugs from generic makers," said FDA secretary-general Siriwat Thiptaradol.

The ministry says it is determined to finalise its decision on compulsory licensing by the middle of next month.

Vichai Chokewiwat, chairman of the Government Pharmaceutical Organisation, said the ministry would like to defer the decision until after the US Trade Representative reviews a list of export products expected to be withdrawn from the US Generalised System of Preferences (GSP) on July 1.

"I want to be sure that any decision made regarding our policy on life-saving drugs will not affect economic and trade relations as a whole," he said.

In early April, the US downgraded Thailand to Priority Watch List status for its handling of intellectual property rights. It was seen as punishment for the ministry's decision to allow compulsory licensing for the HIV/Aids drugs Efavirenz and Kaletra and the heart drug Plavix.

The US embassy said compulsory licensing was just one factor which led to the downgrading. It said the possible withdrawal of certain export products from the US Generalised System of Preferences list would not be linked to the compulsory licensing policy.

Products that face being taken off the GSP list include jewellery, polyethylene, rubber, hand-crafted flowers, television sets and shrimps.

Dr Vichai said the decision on compulsory licensing would also cover the process of registering some important generic drugs which had not yet been introduced to Thailand.

Merck offers free Aids treatment for children  - June 2, 2007

The Public Health Ministry yesterday accepted for consideration American pharmaceutical giant Merck & Co's offer of free anti-Aids medication, in the form of a syrup, to treat 2,500 Thai HIV-positive children. The firm's proposal was seen as another bid by the company to convince the ministry not to put the firm's Aids drug Efavirenz under its compulsory licensing policy.

Food and Drug Administration (FDA) secretary-general Siriwat Tiptaradol said after meeting representatives of MSD Thailand, a subsidiary of Merck & Co Inc, that he would soon discuss the free treatment offer for child Aids patients with local medical experts.

If approved, it would be the first time that Thailand would be using a liquid second-line Aids drug to treat child patients, he said.

"As the firm has refused to further reduce the price of Efavirenz from 762 baht per patient per month, they are now trying to make up for that by offering this syrup for HIV-positive children instead," said Dr Siriwat, who also chairs a committee negotiating a reduction in the price of patented drugs.

According to the Aids Access Foundation, there are around 8,000 children with the infection in the country.

Several rounds of price negotiations between the committee and giant foreign multi-national drug companies have already taken place since the government issued compulsory licenses for three Aids and heart disease drugs, including Abbott Laboratories' Kaletra, Merck's Efavirenz, and Sanofi-aventis' Plavix.

Breaking drug patents will empower the government to manufacture or import generic versions of the medicines to improve access for the poor to expensive life-saving drugs.

Thailand to override more patented drugs: minister  -- Monday, May 28, 2007

BANGKOK -- Thailand, which has overridden international patents on three drugs in the past year, plans to issue two more local licenses this year for copycat versions of medicines, Health Minister Mongkol na Songkhla said on Monday.

The new licenses would be for the country's top killing diseases, especially cancer, Mongkol told reporters, but declined to name them.

"In the remaining six months I have left, we will do it on the drugs that are needed to save the lives of the poor," said Mongkol, referring to the term of the interim army--appointed government due to expire after elections in December.

"Altogether, we will impose compulsory licensing on up to five necessary drugs," said Mongkol, who failed to win a sympathetic ear from trade officials in Washington last week.

Thailand is negotiating with French and American makers of two HIV/AIDS drugs and a heart medicine to lower their prices after Bangkok overrode patents.

The compulsory licensing, which Thailand says is legal under the World Trade Organization's rules, has drawn flak from global drug makers and Washington, but applause from HIV/AIDS advocacy groups.

Mongkol urged drug companies to charge a range of prices for one medicine so that rich and poor would have the same access to the same drug.

"This is not a threat, but an appeal to the drug companies to have sympathy for the poor. One price for the rich and one price for the poor. At the end, it will be win--win for everyone."

Mongkol said there was progress in haggling with two makers of the three drugs to get prices down closer to their generic equivalents, but not with Abbott Laboratories (ABT.N: Quote, Profile, Research, which makes the HIV/AIDS drug Kaletra.

Abbott refused to budge on its offer of $1,000 per patient per year for a heat--stable version of the drug during negotiations with Thai officials this month.

Aluvia is needed badly in tropical Thailand because it does not require refrigeration like Kaletra, eliminating the need for costly cold storage.

Abbott recently cut its price for Kaletra and Aluvia to $1,000 per patient per year in 40 low-- and middle--income countries, but Thailand says it is still too expensive.

Mongkol said Thailand would not scrap compulsory licensing on the three drugs even if the patent owners agreed to sell their products at prices close to generic ones because the rules allowed Thailand to buy generic versions.

"We can't leave generic drugs out of our purchases. Without them, patented drug makers will put price pressure on us again," Mongkol said.

Govt considers revoking compulsory licence for Efavirenz  - May 24, 2007

The government is considering revoking the compulsory licence issued for a generic version of the HIV/Aids medicine Efavirenz after a promising start to informal talks with patent holder Merck & Co Inc in the United States yesterday.

Public Health Minister Mongkol na Songkhla said Merck representatives proposed several interesting options for the anti-retroviral medication which could lead to a win-win solution for both sides.

"Who wants to buy generic drugs for treating patients if the original drug is more affordable?" he said during a teleconference from the United States.

His unexpected comment came just one day after he said the trip to the US had failed to make any inroads into ending the disagreements between Thailand and US pharmaceutical firms.

US Secretary of Commerce Carlos Gutierrez was reported to have put pressure on the Thai team to abandon its policy of compulsory licensing.

The Public Health Ministry last November issued a compulsory licence to import a generic version of Efavirenz from Indian drug maker Ranbaxy which would cost 540 baht per month per patient - considerably cheaper than the original drug, which costs 726 baht per month per patient.

Dr Mongkol did not give details of the options proposed by the New Jersey-based pharmaceutical firm but said it could be a good example for other drug makers whose patents for Aids and blood thinning drugs had been overridden.

Dr Mongkol insisted the government reserved the right to use compulsory licensing if a problem of access to affordable medicines occurred with any life-threatening disease in Thailand.

Thai Public Health, Commerce and Foreign Affairs ministry officials were in the US to explain to US representatives from various sectors, including pharmaceutical firms, the government's decisions to bypass patents on Aids drugs Efavirenz and Kaletra and the heart drug Plavix.

Billy Tauzin, president and chief executive of the Pharmaceutical Research and Manufacturers of America, representing the leading US pharmaceutical research and biotechnology companies, also made it clear to the health minister that leading American drug firms remained deeply troubled by Thailand's use of compulsory licensing.

"Pursuing such drastic measures, as the Thai government has done, not only hurts the innovative engine that helps economies around the world prosper. Worse, it could also limit access to new breakthrough medicines for patients suffering from life-threatening diseases such as HIV/Aids and cancer," he said. "Clearly, Thai patients deserve better."

But Dr Mongkol argued that Washington had received misleading information about Thai policy.

Virat Poorahong of the Thai network Living with HIV/Aids expressed concern at the government's indecisiveness.

"We do not support the government threatening drug companies by announcing compulsory licensing. But we want the government to think and act fast," Mr Virat said.

"We're talking about the lives of half a million HIV-positive people and many more cancer patients who could be short of life-saving medications."

TB Epidemic in Thailand -  May 23, 2007

Some 90,000 TB infections occur every year in Thailand, and about 15,000, or 16.5 percent, of these cases are in Bangkok, according to the Bangkok Metropolitan Administration Health Department. At least 60 percent of the Bangkok patients are younger than age 45 and many live in crowded areas, said Dr. Chanchai Kumphong, the department's deputy director. Dr. Chuchai Sornchamni, senior official of the National Health Security Office, said random checks of people in crowded venues like retail centers have found about one TB case per 500 people.

Moves in the US against Thailand: Bangkok targeted over breaking drug patents  - May 22, 2007

A Republican congressman in the United States has called on President George W. Bush to suspend Thailand's status as a major non-Nato ally pending proof of the restoration of democracy in the kingdom. Mark Kirk submitted a bill to this effect amid sustained lobbying in the US against Thailand's overriding of patents for medicines to treat HIV/Aids and heart disease.

"Eight months after the military coup, despite promises by the military leaders to the contrary, Thailand still has not drafted a permanent constitution, held a referendum, or called elections," Mr Kirk said in the proposal which he tabled on May 17.

The US President should "terminate Thailand's status as a major non-Nato ally until he can certify to the Congress that democracy has been restored to the country," Mr Kirk said in further remarks to the speaker.

He said he was "introducing the Thailand Democracy Act of 2007 to push Thailand's military government to hold democratic elections".

Thailand was designated a major non-Nato ally on Dec 30, 2003.

The status makes the country eligible for several benefits related to the purchase and maintenance of arms from the US, training, and participation in counter-terrorism activities.

Meanwhile, James V. deLong, special counsel to law firm Kamlet Shepherd & Reichert, deplored what he called " a campaign of intellectual property theft" by the government of Thailand.

In a letter to four US government figures, he called on them to look into the matter and to "act swiftly using any and all available political and policy tools at your disposal".

The letters were addressed to Secretary of State Condoleezza Rice, Secretary of Commerce Carlos Gutierrez, Secretary of Health and Human Services Michael Leavitt, and US Trade Representative Susan Schwab.

In a separate move, the Washington-based Hudson Institute has sent a letter to the World Health Organisation's director-general, Margaret Chan, demanding the WHO "investigate important quality and safety issues pertaining to HIV/Aids treatment in Thailand".

Institute director Jeremiah Norris wrote: "Thai patients deserve to be informed of the health consequences inherent in current treatment regimens, especially through the use of an anti-retroviral drug, GPO-VIR."

He urged the WHO chief to sponsor an independent evaluation of GPO-VIR to prove that it is as safe and efficient as the Government Pharmaceutical Organisation, the drug's manufacturer, claims.

The letter was also addressed to the secretary of the US Department of Health and Human Services, Thai Public Health Minister Mongkol na Songkhla, and Suwit Wibulpolprasert, the Thai representative to the WHO.

This follows a recent move by American lobby group USA for Innovation, which published full-page advertisements in Thai newspapers claiming the locally-made GPO-VIR had an unusually high resistance rate among patients using it.

The advertisements prompted the GPO to file a libel charge against the lobbyist on May 15.

US Envoy Wants To Heal Rift - May 22, 2007

Thailand's issuing of compulsory licences to bypass patents on Aids and heart drugs has rattled the multi-billion dollar pharmaceuticals business. The country has been closely watched, particularly by American firms holding patents, and by the US administration.

US ambassador to Thailand Ralph Boyce reflected on the issue in an interview with Apiradee Treerutkuarkul. Following are excerpts from the interview.

What is the US view of Thailand's announcement of compulsory licensing (CL)?

We understand Thailand's rights under Trips [the agreement on Trade-Related Aspects of Intellectual Property Rights] to use compulsory licensing. But it was meant to be the last measure. As far as the embassy is concerned, in terms of transparency, we did not have much advance notice at all that Thailand was going to go ahead with compulsory licensing. The public health minister said publicly that Thailand had tried to get drug companies' attention for two years. That is the minister's statement, but all I can say is that we at the embassy did not have any real warning that it was coming. And the spirit of the Trips agreement is that a compulsory licence is like the last option, and the preferred order of things is the country and the drug companies [first] try to negotiate a mutually acceptable price. Our preferred outcome [for the] US government is that Abbott [Laboratories] and the Ministry of Public Health come up with a mutually acceptable price, because the key here is finding the balance between the high cost of financing innovation and next-generation drugs and the need to be able to provide those drugs to poor people who are suffering from life-threatening diseases. Compulsory licensing is one way to do that, but it is hopefully the measure you use [after] trying everything else first.

Why was there doubt over the transparency of the process in the latest special 301 report of the Office of the US Trade Representative?

As for the special 301 report in which Thailand has been elevated to the Priority Watch List (PWL), what I want to make clear is that the decision was based on the whole spectrum of intellectual property rights (IPR), not just on the CL issue. In fact, the CL issue was just one among many concerns ranging from DVDs, music CDs, books, software and brand-name apparel. Had there not been a flap about CL, I suspect that Thailand would have been elevated to the PWL anyway because we have been hearing from both Thai and American intellectual property rights holders in Thailand that the situation in terms of enforcement has been getting worse. The flap over CL caused most people to conclude that it must be a form of retaliation. It is a timing issue more than anything. I believe that with the overall IPR problems in Thailand, even without CL there still would have been a decision [to put Thailand on the] PWL.

What is the stance of the US on balancing protection of intellectual property rights and humanitarian needs, especially on the issue of access to drugs in developing countries, including Thailand?

Frankly, there are extreme views on both sides. We all know about some of the publications like the Adelman article [in the Washington Times] in the US. Some charges and allegations have been made against the pharmaceuticals industry here.

As usual, the truth lies somewhere in-between ... The humanitarian issues are important and the Clinton Foundation's announcement that it would create a stockpile of drugs for 16 countries including Thailand, where they could make available expensive drugs for the poor, is a good example of creativity that is very useful in finding that balance, because the companies have to spend massive amounts of money to create an innovation and come up with new drugs to help people who need them. Are they supposed to bear the full burden? Are their stock holders supposed to bear the whole burden of the cost of the research, etc? There is an issue of subsidies, and whether some of the medicines should be subsidised by the governments of the countries. So there are a lot of different ways to do this, rather than looking at it in just black and white.

You also had an opportunity to bring pharmaceutical companies to meet the public health minister? What was that all about?

The role of the US government is to try to facilitate conversation and negotiation, striking the balance, suggesting creative ideas, etc. The only thing the embassy was doing in bringing some of the pharmaceutical companies to meet the previous minister [Phinij Jarusombat] was providing the opportunity for the ministry to hear from the companies. The role of the embassy was not advocacy on that particular issue, but simply door-opening. We do this for a number of ministers and a number of different sectors.

Facilitation of communication between American companies and the Royal Thai Government in every sector is one of the most important roles of the embassy. The more conversations and communication the better, as far as I am concerned.

Do you think Thailand is doing enough in trying to communicate with Washington?

This issue has become such a hot, emotionally-charged issue. I certainly understand why that is, on both the Thai and the US sides. But [we should] get away from the emotion and back towards the communication and try to work together, which Thailand and the US have a great track record of doing for decades. It's important to recall that for the United States, some of our most emotional arguments are with our best friends, usually over trade issues.

With either Japan or the EU, we have had some of the most challenging problems with our closest friends over trade issues. That's because when we get into a relationship, [it becomes] very sophisticated and complicated. This issue has captured people's attention because it is so rare for the US and Thailand to have a big flap. It's unusual.

What is your view of the recent advertisement by USA for Innovation against the Thai policy on compulsory licensing?

I would like to distance the US government from this organisation, which most people had never heard of before. The content of the [advertisement] is insulting in many ways. It does not reflect the government's view. I was surprised when I saw the advert in the newspaper. The letter uses extremely strong words and made several accusations that certainly the US government does not agree with.

What are the details of any plan of action?

First of all, we don't have any plan of action ... The approach we are going to take is to sit down with the Commerce Ministry and discuss ways to get Thailand off the Priority Watch List, not hand a list of demands. This is going to be about mutually exploring how to better enforce the existing laws, and how the US might be able to provide any indoor equipment to facilitate that process.

How is the US going to follow up on Thailand's public health policy on compulsory licensing?

We hope to get in close touch with the Public Health Ministry in the new year, after the election. We are looking forward to meeting Dr Mongkol after meetings in Geneva and Washington. I think it is safe for both sides to strive to find ways to avoid having any more compulsory licences. We can't go back and undo what has already been declared. In a couple of cases, they haven't actually imported generic drugs yet and they're still talking with drug companies. So we want to encourage informal talks to avoid formal announcements.

Mongkol to promote safe sex  - May 21, 2007

Public Health Minister Mongkol Na Songkhla will promote safe sex worldwide when he chairs the board of UNAids next month. Dr Mongkol said his new role in UNAids, the world's anti-Aids policy body, would be a good opportunity for Thailand to help promote 100% condom use worldwide.

Dr Mongkol, who was recently picked to succeed the Swedish public health minister as chairman of the UNAids board, said over 40 million people worldwide have the HIV/Aids virus and about 95% of the victims are in developing countries.

He blamed unsafe sex for the spread of HIV/Aids, noting that only 20% of people in risk groups, including sex workers, use condoms.

In Thailand, condom use among sex workers stood at 87%.

Thailand has won recognition for its role in its fight against the deadly virus through the promotion of condom use.

Dr Mongkol will begin serving as chairman of UNAids on June 25. The UNAids board comprises 37 members from 22 member countries and other international organisations.

His term will last for one year. Health ministers from developing and developed countries take turns to chair the organisation.

Cancer next priority in pharma war: Minister unveils new drug licensing plan  - May 16, 2007

Buoyed by global support for its bid to improve access to cheap medicines, the Public Health Ministry is now eyeing cancer drugs as its next target. Public Health Minister Mongkol Na Songkhla yesterday unveiled a plan to enforce compulsory licensing for cancer drugs next.

"It's essential, as cancer ranks among the top five causes of death for Thais, with accidents, HIV/Aids, heart diseases and elderly people's diseases," he said in a telephone interview from Geneva. Previous reports about a move to issue compulsory licences for cancer drugs could not be confirmed until Dr Mongkol spoke yesterday.

The National Health Security Office (NHSO) is currently studying the pros and cons of issuing licences for a group of cancer drugs which are still under patent in Thailand.

In the 2006 fiscal year, the government spent more than 1.2 billion baht on about 50,000 cancer patients receiving treatment through the universal healthcare scheme run by the NHSO.

Dr Mongkol is in Geneva to attend a World Health Organisation assembly before going to Washington next Monday and Tuesday to explain the government's decision to bypass patents on Aids drugs produced by an American company.

He used his European visit to meet for 30 minutes with US Secretary of Health and Human Services Michael Leavitt.

Top of their agenda was Thailand's issuing compulsory licences to import or produce cheaper generic versions of the Aids drugs Efavirenz and Kaletra and the heart disease drug Plavix.

Kaletra is made by US-based Abbot Laboratories.

Dr Mongkol claimed Mr Leavitt understood the transparency of Thailand's announcement and showed sympathy for the effort to bypass patents on costly drugs to increase access for the poor.

Thailand has been attacked by US and European drug firms since the announcement of the policy.

Dr Mongkol and Prime Minister Surayud Chulanont have defended the Thai position, insisting the country was not breaking World Trade Organisation rules on the issue.

The US Trade Representative earlier this month placed Thailand on the Priority Watch List for the first time since 1992, citing intellectual rights violations. The government's decision to issue compulsory licences for drugs was one of the issues leading to the downgrading of the country's status.

The US secretary of health and human services urged Thailand to "try harder" to negotiate with drug companies on the issue of prices.

But Dr Mongkol insisted that he would not revoke the compulsory licences for the three costly drugs unless the drug companies cut prices to below the generic versions.

"Let me do my job so that I can help the poor survive deadly diseases like others," he said. Dr Mongkol also said he would make the final decision on whether the government will buy the first batch of the second-line Aids drug Aluvia from Abbott or the Indian generic drug maker Matrix Laboratories, via the Clinton Foundation.

Aluvia is a heat-stable form of Kaletra.

Meanwhile, the Government Pharmaceutical Organisation (GPO), manufacturer of the local anti-Aids drug GPO-VIR, yesterday filed a libel charge against USA for Innovation at Bang Rak police station.

GPO board chairman Vichai Chokewiwat said the libel charge was filed on the grounds that the US firm's printed advertisements were damaging to the GPO and its products. The adverts had shattered the confidence of doctors and patients subscribing to GPO's medicines, he added.

The full-page advertisements in English claimed GPO-VIR was a copy of an HIV treatment, claiming a study by Mahidol University showed a high resistance rate of 39.6-58% among users.

The GPO says the resistance rate is much lower, about 20%.

Abbott backs off, wants to continue sale of Aids drug- May 15, 2007

Abbott Laboratories, one of the three pharmaceutical giants whose drugs face compulsory licensing in Thailand, has backed off from its threats, saying it wants to continue selling its HIV/Aids drugs here.

Previously, the firm planned to withhold sale of a heat-stable form of Aluvia, its HIV/Aids drug, as punishment for Thailand's compulsory licensing policy.

Representatives of Abbott made the company's stance known yesterday while meeting with Food and Drug Administration (FDA) secretary-general Siriwat Tiptaradol. The FDA also met with representatives from Sanofi-Aventis yesterday.

Abbott's new offer was made on condition that Thailand would not impose compulsory licensing on Aluvia and that the price of the drug, at 3,488.20 baht per person per month, or about 34,000 baht (US$1,000) per person per year, would not come down any further.

Dr Siriwat said the FDA would forward Abbott's offer to Public Health Minister Mongkol Na Songkhla. Abbott's Aluvia price will be compared with the prices quoted by India's generic drug maker, Matrix Laboratories, which produces a generic version of Aluvia at 24,324 baht (US$695) per person per year (or 2,027 baht per person per month).

Matrix made the offer to Thailand and 66 other countries which have agreed to purchase the generic drug, together with the US-based Clinton Foundation.

On the two-hour negotiations with Sanofi-Aventis which holds the patent for the heart disease drug Plavix, Dr Siriwat said the drug giant proposed a one-year project to give patients greater access to the medicine. During the one-year period, the firm would make available 3.4 million tablets of Plavix to 34,000 patients.

The scheme would automatically reduce Plavix's price from 90 baht to about 27 baht per tablet. The FDA will forward Sanofi-Aventis' offer to the health minister, said Dr Siriwat. He added that his committee will invite the pharmaceutical firms to discuss prices again on June 1.

Meanwhile, Vichai Chokewiwat, chairman of the Public Health Ministry's panel on compulsory licensing, said that if the Public Health Ministry chose to buy drugs at prices higher than offered by other sources, it must be able to give the public a good reason to justify its decision.

"If we buy the drug [the generic version of Aluvia] from India at US$695 per person per year, next time, we might get the drug at a lower price, probably as low as US$500. If we buy it from the US firm at US$1,000 now, we might have to continue buying it at US$1,000 forever."

THAILAND: US Drug Maker Offers Thailand Further Cuts on Anti- AIDS Drugs  - May 14, 2007

A Thai drug administration official said Monday that Abbott is offering to sell Aluvia, a newer version of its antiretroviral drug Kaletra, at a discounted price. However, the offer is on condition the country does not allow generic copies of the newer product onto the national market, said Siriwat Thiptaradol, secretary-general for Thailand's Food and Drug Administration.

"We have passed this proposal to the [health] minister to decide," Siriwat said.

In January, Thailand began authorizing generic versions of vital drugs, including the AIDS drugs efavirenz and Kaletra. The nation also continued talking with foreign pharmaceutical firms, including Abbott, to secure lower medicine prices. In March, Abbott said it would stop selling new products in Thailand to protest the health ministry's generic drug program.

Abbott has offered to cut Kaletra's monthly per-patient price in Thailand by 40 percent, to 3,488.20 baht ($100 US). But local AIDS advocates said that price move would not extend to Aluvia, which they say many AIDS patients need. Siriwat said Abbott's offer would price Aluvia "at the same price as Kaletra, for 1,000 dollars per person for a year."

A campaigner with Doctors Without Borders said even at the reduced price, Aluvia would be too expensive for Thailand's HIV/AIDS patients. "I think Abbott should offer a better price without conditions," said Kannikar Kijtiwatchakul. "We would suggest the Minister of Public Health to say no to this condition."

Compulsory Licensing: Activists slam 'misleading' advert by US lobby group - May 11, 2007

Health activists have accused the American lobby group USA for Innovation of doing everything in its power to mislead the public about Thailand's efforts to expand access to medicines by overriding drug patents. "They are trying to do everything they can, even buying the media to protect the benefits of pharmaceutical companies they are working for," said former Bangkok senator and Aids advocate Jon Ungpakorn.

He was referring to the American NGO's action in placing full page advertisements in local newspapers yesterday and today.

The executive director of USA for Innovation, Ken Adelman, is a senior counsellor for Edelman Public Relations, which reportedly works for several drug firms.

"Information shown in the ad is completely misleading and baseless," Mr Jon said. The issuing of compulsory licences by the government was totally in line with the World Trade Organisation's rules.

In the advertisement, USA for Innovation says Thailand refused American and European technology at the expense of the poor and sick of Thailand. It also claimed that most Thai people living with HIV/Aids had no access to quality medicines.

It cited a study by Mahidol University stating that the locally-made anti-Aids drug GPO-VIR had between 39.6% and 58% resistance, one of the worst cases of HIV drug resistance in the world.

Government Pharmaceutical Organisation (GPO) deputy director Wanchai Supachaturas said the information presented in the advertisements was wrong. GPO-VIR's resistance rate was about 20%, which was regarded as normal.

HIV-positive people depending on first-line anti-retroviral treatment usually experienced resistance after a few years of use, and then it was necessary to change to a second-line drug.

Mr Wanchai also said he was not acknowledged in the university's study because the official researchers on drug resistance for the GPO and the public health minister were Siriraj Hospital and the Thai Red Cross.

The Public Health Ministry says about 500,000 Thais are living with HIV/Aids. Of these, about 100,000 depend on anti-Aids drugs.

An estimated 20,000 new cases are put on the list of those receiving medicinal treatment from state healthcare schemes every year.

Jiraporn Limpananont, of Chulalongkorn University's faculty of pharmaceutical science, believed the strategy of putting adverts in English-language newspapers was aimed at reaching a group of educated people and some business groups, particularly shrimp and jewellery exporters, which depend on the Generalised System of Preferences (GSP) from the US.

She called on the Commerce Ministry's Department of Intellectual Property not to submit to US demands on several issues, such as patenting on diagnostic and surgical procedures, in exchange for taking Thailand off the Priority Watch List during discussions with US representatives on intellectual property rights today.

The US wants an extension of the patent protection on drugs and agricultural chemical products from two to four years, and that compulsory licensing be used only in emergency situations.

Clinton salutes Thai drug stance: Announces steep Aids medicine price cuts  - May 10, 2007

New York - Former US president Bill Clinton yesterday gave his backing to Thailand and Brazil's recent moves to break Aids drugs patents held by US pharmaceutical companies to reduce the cost of treating the disease.

Mr Clinton also announced that his foundation had negotiated steep price reductions for generic versions of costly, second-line Aids drugs needed when the original medicines fail, as well as for less toxic, easier-to-use first-line medicines combined in a once-a-day pill.

Standing next to Thailand's Public Health Minister Mongkol Na Songkhla, Mr Clinton forcefully endorsed the decision to break patents held by US pharmaceutical companies charging prices the former president described as exorbitant.

"No company will live or die because of high price premiums for Aids drugs in middle-income countries, but patients may," he said.

The new prices would halve the cost of the drugs for better-off developing countries in Latin America and Asia and cut prices by 25% in poor countries, which were already paying lower prices, the foundation said.

The second-line medicines will be bought with more than $100 million (3.47 billion baht) raised by a group of countries led by France. The improved first-line therapies will largely be financed by the Global Fund to Fight Aids, tuberculosis and malaria and other donors.

Second-line drugs have typically cost about 10 times as much as first-line therapies. Costs have ballooned in Brazil and Thailand, which began programmes to provide universal access to Aids treatment years before African countries did, as patients have developed resistance to generic first-line treatments and moved to brand-name second-line drugs.

The Clinton Foundation's willingness to buy the generic drugs from the Indian manufacturers Cipla and Matrix will give developing countries leverage in bargaining with American companies for lower prices on branded anti-retroviral drugs and may embolden some to follow Brazil and Thailand in overriding patents.

Speaking from New York, Dr Mongkol said he believed the support from the former US president was credible enough to clear doubts over the country's motives in challenging the patents of drug firms.

It also boosted his own confidence as he prepares to address the issues of compulsory licensing and the downgrading of the country to the Priority Watch List by the US Office of Trade Representative in Washington on May 21 and 22.

Dr Mongkol said Thailand would also hold out against pressure for it to submit to US demands on several issues in exchange for an upgrade back.

These included permission to patent not only drugs but also diagnostic, therapeutic and surgical procedures for the treatment of humans or animals, which would inevitably force Thais to shoulder high medical treatment costs.

The US has also called for an extension of the patent protection on drugs and agricultural chemical products from two to four years, and compulsory licensing to be used only in emergency situations.

Dr Mongkol and his team travelled to New York early this week to sign an agreement with the Clinton Foundation to buy the generic versions of Aids medicine from India in bulk.

Drug discussion with US needed - May 09, 2007

As Public Health Minister Mongkol Na Songkhla meets with various lawmakers, activists and executives during his trip to the US this week, it's crucial that a serious, honest discussion begins to take shape. Developing countries need to know when and how they can issue compulsory licences under the World Trade Organisation's agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

So far, the real issue of how to provide affordable drugs for poor citizens has been skewed by pharmaceutical industry propaganda, mean-spirited name calling and red herrings. Enough is enough.

First, we heard Ken Adelman, a senior counselor for Edelman Public Relations Worldwide who heads a non-profit group called USA For Innovation, spew venom about how "the Ministry of Health threatened to kidnap American tourists" and Thailand was "stealing American assets for military benefit." His group recently launched a new malicious website called Thailies.com.

Then we saw the US Trade Representative release an incoherent report on intellectual property rights that downgraded Thailand to the "Priority Watch List." Concerning compulsory licensing, the annual 301 Report said "the lack of transparency and due process exhibited in Thailand represents a serious concern" - but it failed to mention exactly what that refers to.

Now that Brazil has joined hands with Thailand and issued a compulsory licence for Merck's Efavirenz, it's time for the world to decide how TRIPS should work. Simply launching vitriolic attacks against a government - or tossing vague, unsubstantiated allegations in an annual report - does nothing to advance this important global debate.

Moreover, the conflict will only grow as more governments decide to implement the TRIPS agreement and issue compulsory licences. So policy-makers and industry officials can work now on a multilateral level to find solutions to disputes, or wait until a full-blown shouting match erupts between developing and developed countries.

We applaud Dr Mongkol's efforts to explain Thailand's use of compulsory licences to the rest of the world. His affirmation last week that the government would issue compulsory licences for no more than five drugs that combat deadly diseases, instead of 20 to 30 medicines as some had speculated, was particularly instructive. As a show of good faith, the government can do some other things as well. It can demonstrate its commitment to enforcing intellectual property rights by strengthening relevant laws and getting tough on piracy of optical discs and trademarked goods.

For its part, the US government needs to step up and take action. Although bureaucrats have found it convenient thus far to defer to the powerful pharmaceutical industry by generally avoiding serious discussion of the TRIPS agreement, it now must provide some leadership. US President George W. Bush's administration should declare unequivocally whether it supports Thailand's compulsory licences. If it does not, it should have the courage to give specific reasons for its position according to international or Thai law, and file a case with Thai courts or the WTO's Dispute Settlement Body. This way, Thailand and all other governments will be clear on when and how compulsory licences can be used to provide drugs to the world's poorest patients.

For instance, the pharmaceutical industry is fond of saying Thailand or Brazil is either 1) rich enough to afford the medicines, 2) does not pay enough for health care or 3) spends too much money on other things like the military (Thailand) or uranium enrichment (Brazil). If the US or other WTO members believe these are reasons to deter the use of compulsory licences, then they should propose changes to TRIPS that take this into account. Proposals could call for a minimum gross domestic product, a minimum level of health care expenditure or a cap on other discretionary spending for a country to use compulsory licensing. It could also call for the end of the provision that Thailand cited in issuing three compulsory licences for drugs that fight Aids and heart disease.At the end of the day, this debate needs sober reflection and innovative thinking by serious policy-makers instead of spiteful half-truths and a misinformation campaign fueled by scheming flaks. Now is the time for serious discourse. Lives are at stake.

Govt critics support its drug policy: Compulsory licensing a 'courageous' step - May 7, 2007

The government is finding support in unusual quarters for its decision to issue compulsory licences for patented drugs, which threatens to have repercussions on bilateral trade with the US. The Campaign for Popular Democracy (CPD), which has criticised the government for its performance, announced yesterday that it backed it on the issue of compulsory licensing.

The Democrat party also rebuked Washington for heaping pressure on the government over the issue.

CPD secretary-general Suriyasai Katasila commended the government for its courage in embracing the public interest.

"It should be an example for the next democratically-elected government to follow," he said.

Mr Suriyasai recommended the government broaden licensing, which currently covers two drugs for treatment of HIV/Aids and one for heart patients, to medicines for other serious illnesses.

Increasing the availability of cheap drugs was an act of "declaring independence" in the realm of medicine, he said.

Issuing compulsory licences was also an act of public health reform, which needed a long-term government commitment for the momentum to be maintained.

"The confederation is asking the US government to stop taking advantage of less developed nations and practising trade policies which cause injustice for them," he said.

Mr Suriyasai sees a dispute brewing between the Public Health Ministry and Commerce Ministry, which may "cave in" to any threat from the US to cut the Generalised System of Preferences (GSP), a trade measure, in retaliation for compulsory licensing.

The government's decision to issue compulsory licences for generic versions of the Aids drugs Efavirenz and Kaletra and the heart drug Plavix prompted the Office of the US Trade Representative (USTR) to downgrade Thailand to a country deemed to have poor intellectual property protection.

A delegation from the Public Health Ministry yesterday left for the US to clinch a deal with the Clinton Foundation to buy drugs in bulk at modest prices.

The team is being headed by Public Health Minister Mongkol na Songkhla and Vichai Chokewiwat, who leads the panel in charge of compulsory licensing. They will return in four days, before leaving for the US again on May 21 to explain to Washington the reasons for the government's stance.

Dr Vichai said yesterday that the trip would show the world that Thailand was willing to pursue other options besides licensing.

The country's pharmaceutical development had been hampered by the requirement the government wait until drug patents expire before it can produce generic versions. In addition, a clause in the law giving the government control over prices of patented drugs was deleted many years ago.

Dr Vichai brushed aside recent criticism by USA for Innovation, an NGO, of the government's stand on compulsory licensing.

The Washington Times recently published an article critical of the coup, the government's economic policies and its use of compulsory licensing. The article was written by Ken Adelman, who is a senior counsellor of a public relations company which has ousted prime minister Thaksin Shinawatra among its clients. He is also an executive director of USA for Innovation.

Dr Vichai rejected Innovation's suggestion the government decided on licensing to save on public health spending so that it could increase defence expenditure.

The Democrats warn the US may have a hidden agenda in placing Thailand on priority watch. The government should begin talks with the US to find a way out of the crisis.

Generic Drugs/Pharmaceutical Row: Minister to clarify stand on issue  - May 05, 2007

Science and Technology Minister Yongyuth Yuthavong has made preparations to explain Thailand's position on compulsory licensing policies to US pharmaceutical firms during his visit to the United States this week.

The minister said the country needed to explain the issue after the Public Health Ministry's decision to implement compulsory licensing of generic versions of the Aids drugs Efavirenz and Kaletra and the heart drug Plavix - a move that prompted the Office of the US Trade Representative (USTR) to downgrade Thailand to a country deemed to have poor intellectual property protection.

"I am not a lobbyist for the issue. What I have been doing is to assist the Public Health Ministry in clarifying our stand on the issue," Mr Yongyuth said.

"My message is that what we have been doing is for humanitarian reasons and to stress that we have not breached any laws. Our action is in line with the WHO's regulations," he said referring to the World Health Organisation.

Mr Yongyuth is scheduled to attend a programme for international scientists and researchers working to find breakthroughs for treatments of diseases in the developing world. He is attending in his capacity as member of the committee on Grand Challenges in Global Health meeting from May 5-9.

The programme, which will also be attended by some of the world's leading pharmaceutical firms, is funded by the Bill & Melinda Gates Foundation, owned by multi-billionaire Bill Gates.

However, Mr Yongyuth said he would not be accompanying a delegation led by Public Health Minister Mongkol na Songkhla, who is set to sign an agreement with the Bill Clinton Foundation and 16 developing countries on May 8 to jointly procure cheaper drugs.

Dr Mongkol yesterday met with former Bangkok senator Jon Ungpakorn, who is executive secretary-general of the Aids Access Foundation, to discuss the issue of compulsory licensing and the USTR's decision to put Thailand on the priority watch list.

Mr Jon said after the meeting that he told the Thai delegates to be prepared for three questions that are likely to be asked by the US administration and American drug manufacturers.

First, they would question the authority and legitimacy of the current government, which was installed by coup-makers, to enforce compulsory licensing.

Second, the Thai delegation must also be ready to explain why the government did not attempt to negotiate with American drug firms before applying compulsory licensing.

Third, the drug firms and the US administration may ask about reports that the compulsory licensing enforcement in Thailand is set to extend to 20-30 more types of patented medicines.

Mr Jon said the best policy for the government is to stand its ground on the issue. He said the Public Health Ministry did not need to hire lobbyists to defend its decisions.

He saw the USTR's move to downgrade Thailand to a country with poor intellectual property protection as a form of a threat, but one that fell short of lifting the generalised system of preferences (GSP).

Mr Jon said US drug firms wield a great amount of influence on US politicians. They donate huge political funds for them to use in running election campaigns.

He said some US senators who petitioned against Thailand's compulsory licensing were recipients of the drug firms' donations.

However, the US public is aware of this situation and the lobbying by the drug firms, Mr Jon said, adding that the Thai government can correct their misunderstandings by telling them the truth about the need for compulsory licensing.

AIDS Activists Protest US Decision to Place Thailand on List of Copyrights Violators  - May 04, 2007

Activists protest outside the US embassy against the US Trade Representative's decision to put Thailand on a priority watch list of countries closely monitored for their protection of intellectual property rights, in response to the government's enforcement of compulsory licensing of imported medicines.

Prime Minister Surayud Chulanont is confident the government can explain to the world why compulsory licensing of patented foreign medicines is necessary.

The government also claims to have received many messages of support from foreigners who support the policy.

"We stand by what we have done, and we can explain our actions to the world community," he said.

Thai officials needed to work with US officials and resolve the dispute over the decision by the US Trade Representative Office to downgrade Thailand to a country deemed to have poor intellectual property protection.

Gen Surayud said the Commerce Ministry would handle copyright and intellectual property violations.

The need to uncover any link between ousted prime minister Thaksin Shinawatra and the USTR's decision was secondary to explaining the need to use compulsory licensing.

Public Health Minister Mongkol Na Songkhla said he had received more than 200 letters and email messages from foreigners showing their support for Thailand's compulsory licensing of generic versions of the Aids medications Efavirenz and Kaletra and the heart drug Plavix.

The minister insisted the government acted with good intentions, of giving the poor access to inexpensive and quality medical treatment.

He would travel to the US along with Vichai Chokewiwat, chairman of the Government Pharmaceutical Organisation board, who would sign a contract with the foundation run by former US president Bill Clinton.

The Clinton Foundation would help Thailand negotiate with Aids drug makers in the US to ensure that the price of medicines was affordable for HIV/Aids patients.

Council for National Security chairman Gen Sonthi Boonyaratkalin said he had no information about Mr Thaksin's supposed link to Thailand's downgrading by the USTR.

He also rejected a US critic's comment that Thailand cannot afford to buy Aids drugs because much of the national budget had gone on funding the army.

Gen Sonthi said the army had its own annual budget, and had not taken other agencies' money.

Health activists yesterday protested outside the US embassy against Washington's decision to put Thailand on the priority watch list.

Virat Poorahong, leading the Thai Network of People Living with HIV/Aids, believed the US move was in response to the government's enforcement of compulsory licensing, even though the US ambassador had said compulsory licensing was just one concern, but not the main reason.

However, an expert on international trade law at the University of Wollongong in Australia, Jakkrit Kuanpoth, said the government should not be too worried about the priority watch list.

It was less serious than the priority foreign countries list under the US Omnibus Trade and Competitiveness Act, which provides for trade retaliation measures, he said.

Health vs economic interests: Why are the ministries of commerce and foreign affairs doing nothing to explain to the outside world Thailand's decision on compulsory licensing?  - May 04, 2007

In a move that hopefully will instigate all developing countries to step up their rightful fight for access to affordable medicine, the Thai government's bold decision to bypass patent laws on three drugs for the treatment of Aids and heart ailments is, however, coming under increasing pressure from domestic as well as international politics.

From abroad, the United States' Office of the Trade Representative's downgrading early this week of Thailand on its "Priority Watch List" of countries to be closely monitored for protection of intellectual property rights, is viewed as a punishment for Thailand's announcement of compulsory licensing (CL) for the Aids drugs Efavirenz and Kaletra and the heart drug Plavix.

This downgrade could lead to a lifting of the generalised system of preferences (GSP) currently enjoyed by Thai exporters, particularly in the gems and jewellery sector whose trade volume is worth around 7.5 billion baht annually.

Despite US ambassador to Thailand Ralph Boyce's statement that the USTR's decision did not stem from the compulsory licensing alone, the issue is the only new reason cited in the Special 301 Report, the USTR's annual review of the global state of intellectual property rights protection and enforcement.

Public Health Minister Mongkol Na Songkhla, who spearheaded the daring policy to give wider access to important medicines for people who cannot afford expensive drugs, and Department of Intellectual Property chief Puangrat Assawapinit, were not really surprised.

Dr Mongkol insists Thailand's move is lawful and fully within the framework allowed by the World Trade Organisation's Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) and that the Thai people's health should come first.

"We carefully considered the economic interest and the matter of life and death of the people before announcing the compulsory licensing. Economic interests cannot be compared with saving human lives and protecting the public health," Dr Mongkol said.

The health minister said the latest response from the United States clearly demonstrates the clout American pharmaceutical companies have on the USTR.

Thailand's issuing of CL has rattled the multi-billion-dollar "big pharma" business from the very start. Drug firms continue to claim that the move to forcibly substitute more expensive, patented drugs for lower-priced generic versions would destroy the pharmaceutical industry, and make patients happy for a day but produce long-term shortages.

Thanks to Thailand's implementation of the compulsory licensing for the Aids drug Efavirenz last November, the patent owner Merck announced a worldwide price cut to 725 baht from 1,500 baht per month per patient.

In addition, the announcement of the licences to override patents for Aids and heart drugs Kaletra and Plavix in late January has led to radical changes in the response from Kaletra's patent holder Abbott Laboratories.

The pharma giant at first declared it would not register new drugs in Thailand but later changed its tone to offer a price cut for both Kaletra and its improved version called Aluvia at an equal price of 3,488.20 baht.

Although the planned CL has not yet been implemented and the decision to buy either the original or generic drugs will not be made until the existing stockpile of these medicines runs low, probably in August, the movement has evidently proven effective and beneficial to Thailand.

It has also offered hope for developing countries to follow in this direction if they hope to have any bargaining power with the powerful pharmaceutical business.

There is no doubt the drug companies including the US-based Abbott will lobby their governments to put pressure on Thailand for breaking their drug patents.

There is the question, however, that whether the Thai attempt to bypass patents - an action permitted by the WTO - so as to save millions of lives, should be tied to the illegal violation of property rights relating to entertainment or luxury products, leading to trade retaliation.

"Unfortunately, most people affected by these diseases are the poor who have neither power nor money to pay for lobbyists unlike the pharmaceutical giants.

"For a small, low-income, developing country like Thailand, even if what we've done is the right thing, it can turn out to look wrong in the eyes of big countries like the United States," Dr Mongkol said.

He added that the United States itself had granted compulsory licenses for several drugs.

In 2005, the Federal Trade Commission announced a consent agreement which would protect competition and consumers in several significant medical device markets.

Abbott was awarded a compulsory licence for Boston Scientific's patented stent technology that is now poised to generate huge profits for the firm, after a study showed the drug-coated stent was better at treating clogged heart arteries.

With a per capita GDP of roughly one-sixteenth that of the United States, the Thai health system is, on the other hand, under threat of going bankrupt: one of the biggest expenses is the cost of medical treatment.

A huge healthcare budget has been spent on providing free drugs under the three health schemes for civil servants, employees of the private sector and the estimated remaining 47 million population.

Among these drugs are costly anti-Aids medicines and those for chronic illnesses such as cancer and heart disease which are the country's top three causes of death each year.

Therefore, seeking the right to access cheaper drugs via compulsory licensing seemed the last resort to save the national health system.

Is the Public Health Ministry the only Thai agency which sees the importance and necessity of breaking the drug patents for the survival of its healthcare services? And here comes the squeeze from within. Since the announcement was made several months ago, Dr Mongkol seems to be the only minister defending the action. No support has come from such related agencies as the Commerce or Foreign Affairs portfolios.

Former Bangkok senator and health activist Jon Ungpakorn pointed to the lack of unity among the relevant ministries in pushing for the CL to succeed, as a possible flaw which Washington may have picked up on before bringing in the trade retaliation.

After this, the US can negotiate with Thai trade-related authorities who are seen as being more keen on commercial interests than on in-depth details related to access to affordable medicine.

"The three involved authorities should have worked together as a team rather than deserting the Public Health Ministry to handle the task alone. We're living in a world of capitalism in which everything, even the matter of life and death of one person, can be turned into profit and benefits for others," Mr Jon commented.

"The issue of CL is very important not only for Thailand but also other developing nations. If involved authorities of this government fear to do the right thing for the nation simply because of a threat from a big country this time, don't even hope that we will have a chance to fight for anything right in the future," Mr Jon said.

As executive secretary-general of the Aid Access Foundation, Mr Jon late last month participated in the annual meeting of Abbott Laboratories stakeholders held in Chicago, and found there was a lot of misunderstanding in the eyes of foreigners regarding Thailand's decision to push for CL, mainly because of the lobbyists for drug companies. Some claimed Thailand was breaking the patents for up to 30 drugs.

He believed the Ministry of Foreign Affairs should be more responsible in explaining the issue - of Thailand's necessity and needs - to the global community so that they will at least understand that the action taken has been a lawful one.

Meanwhile, Jiraporn Limpananont, an academic at Chulalongkorn University's Faculty of Pharmaceutical Sciences, said it was essential that the Commerce Ministry and the Department of Intellectual Property proceed cautiously and leave some room for the protection of public health when amending the Patents Act.

The amendment was part of the US' proposal on the protection of intellectual property (IP) rights, which would be included in the still-to-be concluded Thai-US FTA pact. The US has demanded Thailand allow it to patent not only drugs but also diagnostic, therapeutic and surgical procedures for the treatment of humans or animals, which would inevitably force Thais to shoulder high medical treatment costs.

The US has also called for a three- to 10-year extension of the patent protection on drugs and agricultural chemical products.

Ms Jiraporn foresaw that the Thai public welfare system, including the 30-baht healthcare scheme, would completely collapse if the government submitted to Washington's demands.

However, according to the revised version of the Patents Act that was put to the scrutiny panel of the Prime Minister's Office and which awaits cabinet approval for the National Legislative Assembly's endorsement, the amendment includes an alteration to Article 7 of the law to allow evergreening patents on plants and animals, which would enable the patent holder to extend their patent duration by declaring new chemical substances.

Another concern is the proposed cancellation of the pre-grant opposition system. It has been the practice to allow concerned people to oppose a patent application before it is granted. However, the ministry proposed a so-called "post-grant opposition" for the amendment, meaning they would grant a patent first and listen to any opposition later.

Ms Jiraporn also said that allowing the Commerce Minister to identify which illnesses are in line with the language of the Doha Declaration, was highly inappropriate.

Banyong Limprayoonwong, deputy director-general of the Department of Intellectual Property, said that health officials could not do anything to the amended Patents Act since it had already passed the revision process. It was now up to the cabinet's prerogative to either accept or reject the submitted draft before sending it to the National Legislative Assembly for endorsement.

Though it may appear that Dr Mongkol and the Health Ministry have won this round in expanding access to drugs at more affordable prices for the people, the battle is proving to be longer and more arduous than anybody may have thought.

With continuing pressure from the United States and from our own Commerce Ministry to amend the Patents Act, it remains to be seen if public health will triumph over commercial interests and win the war to make drugs cheaper for everyone in the long run.

Thailand on priority watch list: US move ridiculed by cheap drug advocates  - May 2, 2007

The US administration has downgraded Thailand to a country with poor intellectual property protection in a move ridiculed by Thai advocates of cheap drugs. The US Trade Representative Office (USTR) on Monday placed Thailand and 11 other countries, including China, India and Russia, on the "Priority Watch List" of countries to be closely monitored for their protection of intellectual property rights.

It is a downgrading from the "Watch List" which Thailand was previously on.

The downgrading, outlined in the USTR annual report on intellectual property protection, came as no surprise after the Public Health Ministry enforced compulsory licensing on imported drugs, drawing protests from US drug firms.

Abbot Laboratories was among firms which asked Washington to put pressure on Thailand for allegedly stealing their intellectual property.

But US ambassador to Thailand Ralph Boyce yesterday said the USTR decision did not only stem from compulsory licensing.

"True, compulsory licensing in Thailand is one of the concerns, but it is not the main reason for Thailand being placed on the Priority Watch List," he told a press conference.

Thailand's protection of copyrights and intellectual property has been seen to have weakened over the past year, but there were also other reasons for the downgrading, he said.

"The fact that Thailand is being placed on the Priority Watch List reflects US and international concerns toward Thailand's recent economic policies such as the Foreign Business Act amendment, the capital control measures and the Retail Act," Mr Boyce said.

The US last placed Thailand on its Priority Watch List from 1989 to 1992. It upgraded Thailand to the Watch List in 1993 because of improved measures to tackle intellectual property offenders.

According to the US International Intellectual Property Alliance, American businesses selling copyrighted products and services lost US$368 million in Thailand last year, up from $355 million in 2005 and $184 million in 2004.

Under the Special 301 Act, Washington can take trade action or seek dispute settlements against countries on either the Priority Watch List or the Watch List.

Public Health Minister Mongkol na Songkhla vowed to go on lowering drug prices to expand the poor's access to essential medicine.

"We have not done anything wrong. We followed the process closely by announcing the plan to use compulsory licensing before implementing it," he said. The move was "absolutely legitimate" and in line with World Trade Organisation (WTO) rules, the minister said.

The decision to put Thailand on the Priority Watch List reflected the influence drug firms had over the USTR, he said.

The ministry implemented compulsory licensing for the Aids drug Efavirenz in November. The patent owner, Merck, later announced a worldwide cut in the price of the medicine to 725 baht. In Thailand, patients previously paid 1,500 baht a month to use Efavirenz.

The ministry announced a similar policy for heart drugs Kaletra and Plavix in January. But it has not yet been implemented because there is enough stock of these drugs to last until August.

Health activist Jon Ungpakorn urged the Commerce and Foreign ministries to work with the Public Health Ministry to defend compulsory licensing rather than leave the task to this ministry alone.

Intellectual property law expert Jade Donavanik said compulsory licensing was for government use and did not violate the WTO agreement. "It is unfair to interfere with another country's sovereignty by taking unilateral trade action like this," he said, referring to the USTR move.

Activists sound warning on US campaign: Drug firms backing anti-Thai govt ads - April 29, 2007

Thai health activists yesterday denounced American organisation USA for Innovation for running an advertisement condemning the government's decision to override the patents on American medical innovations. Nimit Tienudom, chairman of the Aids Access Network, questioned the organisation's motive, saying that the move was aimed at protecting the interests of giant American drug firms instead of the interests of the public.

The organisation was not a "non-profit" organisation working on the protection of intellectual property and innovation as it had claimed, but in fact a proxy of the American pharmaceutical businesses, he said.

USA for Innovation on Wednesday kicked off an advertising campaign against "Thailand's Theft of American Assets".

The campaign includes a full-page advertisement in the Wall Street Journal, and highlights a recent movement by the Thai 'military regime' to steal American medical innovations, according to the organisation.

Over 35,00 letters would be delivered to President George W Bush, US administration officials and the congressional leadership urging Washington to "take retaliatory action in the form of trade or economic sanctions or the removal of military aid".

The advertisement, under the headline "Slouching Towards Burma", says Gen Surayud Chulanont is taking Thailand down Burma's path, by lining the military's pockets with pay increases of $9 million and new military spending of $1.1 billion.

"Then coup leaders hastily imposed draconian measures on foreign-owned companies like capital controls, restrictions on business advertising and stealing American assets for military benefit," the advertisement says, referring to Public Health Minister Mongkol na Songkhla's recent decision to break the patent of Aids and heart disease drugs produced by US drug firms, including Abbott Laboratories and Merck.

"In a global economy, American innovation is our comparative advantage.

We urge President Bush and the Congress to protect America's interest and the people of Thailand," it says.

The agency also ran an online action campaign on its website, www.usaforinnovation.org, where people could petition Thai ambassador to Washington Krit Garnjana-Goonchorn.

Another activist said Ken Adelman, USA for Innovation's executive director, is a senior counsellor at Edelman Public Relations Worldwide, which runs public relations campaign for several giant drug firms in the US including Abbott, Merck, and Sanofi-Aventis.

Activists rally against US pharma giant: Want govt to decide if drug withdrawal legal  - April 27, 2007

Around 100 health activists rallied at the Commerce Ministry yesterday to press it to decide whether the move by Abbott Laboratories to withdraw the planned introduction of new drugs into the country violates the law.

The rally was also part of a worldwide protest against the US drug giant's stance after the government's decision to issue compulsory licensing to override patents on its key Aids drug Kaletra.

The decision allows the country to import or produce the generic version to expand public access to affordable medicine.

Protesters against Abbott, including pharmaceutical science academics as well as Aids and consumer rights groups, submitted a petition to Siripol Yodmuangcharoen, director-general of the Internal Trade Department.

They also asked the department to set up a panel to investigate the issue, and to review the drug pricing system within three months.

"We want to know if the company's action is legitimate or not since its action affects the opportunity of all Thais to access newly-invented medicines necessary for advanced medical treatment," said Nimit Tienudom, chairman of the Aids Access Network.

The two-page petition mainly questions whether the drug firm's action is against the Trade Competition Law.

The withdrawal of registration with the Food and Drug Administration affected not only patients in need of advanced medicinal treatment but also distributors incapable of importing 10 new drugs for use in the country, the letter says.

In addition, imports of Abbott drugs cost over 1.16 billion baht in 2005.

Any withdrawal of the medicine without appropriate reason may result in an insufficient amount of related drugs reserved for treating patients, it adds.

About 10,000 copies of pamphlets were also distributed in the business district of Silom to publicise the problem of affordable drug access in Thailand and campaign for a boycott of medicines and other products of the US pharmaceutical firm in response to its action.

Meanwhile, two US law professors criticised Abbott's law firm Baker & McKenzie for misleading the public that the government's move to resort to compulsory licences was unlawful under the World Trade Organisation's (WTO) Trade-Related Aspects of Intellectual Property Rights (Trips).

Brook K. Baker, a professor at Northeastern University, and Sean Flynn from Washington College said the Trips agreement contained no limitations on how compulsory licences can be granted.

They quoted the agreement stated in the Doha Declaration, released at the end of the World Trade Organisation meeting in November 2001, as saying: "Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted."

Thus, if Thailand wanted to conserve resources in its world-renowned HIV/Aids treatment programme, that decision was 100% lawful, they said.

Public Health Minister Mongkol na Songkhla said Brazil and five other countries had asked for information regarding Thailand's move on compulsory licensing for the drug before proceeding with similar policies.

Brazil is likely to issue compulsory licensing for the Aids drug Effavirenz after the company declined to reduce the price from $1.59 (52 baht) to $0.65 (21 baht) per tablet, as requested by the government.

Editorial: Abbott wrong to target Thailand  - April 25, 2007

The latest offer by Abbott Laboratories to register second-line Aids drug Aluvia in Thailand if the government drops its compulsory licence is a step in the right direction. But the government should reject any offer that calls for dropping the compulsory licence, which is a right guaranteed in the World Trade Organisation's agreement on Trade-Related Aspects of Intellectual Property (TRIPS).

Indeed, the government's decision to issue a compulsory licence for Kaletra has already reaped benefits, and not just for Thailand. Although Abbott pulled registrations for Aluvia - a heat-stable form of Kaletra that does not require refrigeration - and six other new drugs in Thailand, the company did reduce the price of  both Kaletra and Aluvia  for 45 low- and middle-income countries to $1,000 per-patient per year from $2,200 previously.

Thailand was included in this list of countries, but Abbott singled Thailand out by refusing to register Aluvia here. In essence, the pharmaceutical giant was hoping to placate growing calls for an international boycott while still slapping Thailand for daring to take advantage of a WTO agreement on intellectual property rights. The message to the rest of the world was clear: Issue a compulsory licence, and be punished.

But Thai negotiators should accept no punishment from Abbott for issuing a compulsory licence. And that's what makes Abbott's latest offer unacceptable.

First of all, Abbott will still refuse to register six new drugs in Thailand to protest its use of the compulsory licence. This is punishment enough. If Thai policy-makers accept Abbott's latest price reduction on Aluvia - which has been extended to Brazil, China, India and about 40 other countries with no such penalty - then it will have accepted the drug company's right to sanction the country for following an international agreement accepted by 150 WTO members.

Secondly, if Thailand agrees to drop the compulsory licence, it would be giving up a right guaranteed in the TRIPS agreement, which could set a dangerous precedent for future talks with drug companies.

Thailand should not have to apologise or give up rights guaranteed in international treaties for Abbott to register Aluvia and the six other drugs it withdrew. To the contrary, the Thai government's decision to issue compulsory licences has led to cheaper Aids drug prices around the world.

The issue is all about finding the cheapest drugs available for poor patients. As the Public Health Ministry has repeated again and again, the Thai government is not interested in seeking price reductions for rich patients who can afford to pay $2,200 per year for Kaletra or Aluvia. Policy-makers are simply trying to secure cheap prices only for Aids patients who can't afford the drugs and wouldn't buy them anyway.

If Abbott wants to blame anyone for compulsory licences, it can start pointing the finger at the WTO's 150 member governments, including the United States, which agreed that developing countries should have the right to use them. Indeed, TRIPS is the world's foremost agreement on intellectual property rights. It's unacceptable for Abbott to scold Thailand about intellectual property rights when the government has complied with TRIPS throughout the process. Even World Health Organisation head Margaret Chan said Thailand's compulsory licences were "fully in line with the TRIPS agreement."

If Abbott thinks otherwise, it should ask the US government to file a complaint at the WTO's dispute settlement body. If Abbott doesn't do that, it should not expect Thailand or the rest of the world to follow the company's own guidelines on intellectual property.

Although Thai policy-makers courageously started this discussion on intellectual property rights, now the debate must move beyond the country's borders. The WHO and other international bodies should make it clear where they stand.

If TRIPS is nothing more than empty promises, then it must be reworked. If the majority of trading nations oppose compulsory licensing, then it should be done away with altogether. Or if more conditions must be placed on using compulsory licences, then by all means they should be put in place.

But it's the height of hypocrisy for governments to pass a ground-breaking agreement to expand drug access to poor patients, and then heap vitriol on a country that actually tries to implement the deal.

Generic drug maker offers cheaper Aluvia  - April 25, 2007

A generic drug maker in India is offering Thailand a cheaper version of the Aids drug Aluvia after Abbott Laboratories, the patent holder, offered to sell the anti-retroviral drug at a reduced price. Vichai Chokewiwat, chairman of the Public Health Ministry's panel on compulsory licencing, yesterday said a drug company in India was offering a price 15% below Abbott's new price for the patented version.

However, he said, he still expected better deals from both the original and generic producers. "Thailand is a drug buyer. We have to be smart and spend taxpayers' money on the best offer," he said.

Abbott has offered to cut the price of its life-saving Aids medicine to $1,000 (32,500 baht) per patient per year.

The price also matches the generic version sold in developing countries and the price of anti-Aids drug Kaletra, which the firm offered to the Thai government for 3,490 baht per patient per month.

Aluvia, a newer version of Kaletra, is one of several drugs for which Abbott has recently withdrawn applications for regulatory approval for use in Thailand.

The withdrawal was made in protest against the military-appointed government's decision to override the firm's Kaletra patent and allow the production and import of generic versions.

Dr Vichai welcomed Abbott's latest price offer on Aluvia, saying it was "the best deal ever". But any decision to accept or reject the offer would not be made until the existing stock of Kaletra was running out, he said.

Disease Control Department chief Thawat Sundarachan said the current stockpile should be enough to treat HIV-positive Thais until the end of this year.

Meanwhile, the Pharmaceutical Research and Manufacturer's Association of Thailand yesterday called on the government for more dialogue about the country's generic drug programme.

"We need to work together in a spirit of joint endeavour if we are to succeed in helping Thai patients," the group said in a statement. "There is so much more that can be provided to patients by industry and government engaging in a dialogue that is focused on securing better health outcomes in Thailand."

The association represents 43 drug giants from Europe, Japan and the US.

Talk to drug firms first, says US ambassador - April 24, 2007

US ambassador Ralph Boyce has urged Thailand to negotiate with US pharmaceutical companies for a reduction in the price of patented drugs, rather than acquiring cheap generic versions through compulsory licensing.

Mr Boyce made the call during a one-hour meeting with Public Health Minister Dr Mongkol na Songkhla and other senior health officials yesterday.

The ministry has already resorted to compulsory licensing for the importation and production of generic versions of Aids-related medicines and a blood thinning drug.

After the meeting, Mr Boyce suggested the parties concerned should talk and reach a common ground on reasonable prices for the drugs.

While he realised that Thailand had the right to use compulsory licensing under an agreement with the World Trade Organisation (WTO), he would like an attempt at negotiating first.

Compulsory licensing may not be necessary if the prices of patented drugs were reduced through negotiations between the Thai government and the US drug companies, he said.

The ambassador said the US government had yet to make any decision concerning the listing of Thailand as a patent violator, saying the matter did not only involve compulsory licensing.

Dr Mongkol said the US ambassador understood Thailand's stance on compulsory licensing and wanted to see the interests of all parties protected.

"The US is a law-abiding country," he added.

The minister was scheduled to begin a two-day visit to the US tomorrow to explain the need for compulsory licensing.

He was forced to postpone the trip for three weeks because of health problems.

Govt seeking new generic imports  - April 19, 2007

Thailand wants to import a generic version of the anti-Aids drug Aluvia, in tablet form, from makers in India. The move comes after the patent holder, Abbott, withdrew its introduction of the medicine to the country after the government announced compulsory licensing.

A source said the Public Health Ministry was looking for generic drug producers of the new tablet form of the protease inhibitor lopinavir/ritonavir in India. Thus would offer HIV-positive people with resistance to first-line drugs such as the locally-made GPO-VIR access to a superior regimen of the second-line Aids drug.

The decision was made after the US-based company opposed the government's decision to go for compulsory licensing and threatened to withhold the introduction of new drugs in Thailand, including Aluvia which is an improved version of Kaletra, the source said.

It was possible that the government would receive cooperation from international organisations, including the Clinton Foundation, to help negotiate the price with the generic drug makers in order to ensure that the price of Aids drugs would be affordable for Thai people living with HIV/Aids, the source said.

The objective of the Clinton Foundation HIV/Aids Initiative (Chai) is to make treatment for HIV/Aids more affordable and to implement large-scale integrated care, treatment and prevention programmes.

Virat Poorahong, head of the Thai Network of People Living with HIV/Aids, said the generic version of Aluvia costs about 4,000 baht per month. However, this improved version of Kaletra could be reduced to below 2,000 baht to compete with the Kaletra price offered by Abbott.

Abbott has decided to lower the price of Kaletra to 3,488.20 baht in Thailand. However, it is unclear whether the ministry will accept the offer or proceed with its plan to import the generic version from India under the compulsory licensing.

HIV-positive Thais with resistance to first-line drugs spend up to 11,850 baht per month to buy such medicine.

Last year, Abbott announced that it would sell Aluvia at a price of $2,200 (71,000 baht) a year in developing and middle-income countries including Thailand.

However, the drug firm decided last month to withdraw its introduction of the medicine and other new drugs in Thailand in opposition to the government's compulsory licensing decision, which allows the state to override drug patents to import or produce cheaper versions of the medicine for emergency use.

Mr Virat said he and former Bangkok senator and health activist Jon Ungphakorn were also invited by a group of shareholders in Abbott Laboratories to attend the annual stockholders meeting in Chicago on April 27 and address the necessity of adopting compulsory licencing to give Thai people access to affordable medicine.

Public Health Minister Mongkol na Songkhla and his special adviser Suwit Wibulpolprasert will also be going to Washington to defend the decision to use compulsory licencing. They say it does not contradict the World Trade Organisation's agreement on Trade-Related Aspects of Intellectual Property.

Cost of new drugs must be stated: FDA: Law will protect rights of consumers - April 17, 2007

Pharmaceutical firms will be required to declare the cost of each new drug listed for introduction in the country in a bid to protect consumer rights, Food and Drug Administration (FDA) secretary-general Siriwat Thiptaradol said. The declaration of production costs will be stipulated in a new drugs bill now being scrutinised by the Council of State.

The move, which is aimed at seeking a balance between the interests of patent holders and the public, might affect sales to some level, he said.

However, he did not think it would mean a double standard for the makers of existing drugs.

"Drugs are a special product and the FDA has a duty to ease the problems of drugs access while protecting consumers' rights. In the meantime, we also have to ensure the move will not severely hurt the benefits of drug companies," he said.

In February, the government announced a decision to adopt compulsory licensing for importing or producing copycat versions of costly Aids and heart drugs Efavirenz, Kaletra and Plavix.

Abbott Laboratories, the patent holder of Kaletra, rejected the move by withholding a plan to introduce new drugs - including Aluvia, which is an upgraded formulation of Kaletra - in Thailand.

However, the company earlier this month decided to cut the Kaletra price to 3,488 baht per month, down 40% from its previous proposal. The new price could be cheaper than the generic version of the anti-Aids drug.

But the Public Health Ministry has yet to make a final decision on whether to accept the company's offer or maintain its previous plan to import generic versions of the drug.

Dr Siriwat said he believed the new law would not cause other drug firms to withhold the introduction of new drugs in Thailand as Abbott did.

"The drug price should be affordable for people in each country, but that is not always the case. For example, leukaemia drugs cost a patient nearly 100,000 baht a month, whereas the average monthly income of Thai people is only 10,000 baht. As a result, some patients were almost bankrupted by the overpriced drugs necessary for treatment," he said.

Apart from the issue of overpriced drugs, pharmaceutical officials will keep a close watch on the marketing and promotional tactics of drug firms, particularly the way they sponsor trips for health professionals to attend seminars and conferences abroad.

Jiraporn Limpananont, an academic at Chulalongkorn University's faculty of pharmaceutical sciences, said drug companies have invested heavily in marketing and promotional campaigns, and that made drugs too costly.

This is unfair to consumers, she said.

"It's necessary to seek a balance between the patent holders and the public. Live-saving drugs should not be products that only the well-to-do can afford," she said.

Ms Jiraporn also questioned the proposed revision of the patent law by the Department of Intellectual Property, which would allow opponents of patents to contest the process only after approval is given.

Without "pre-grant" opposition, local drug firms would not be able to produce generic versions of patented drugs until disputes were over, and that would mean Thai consumers would be stripped of fair access to cheap drugs, she said.

Abbott agrees to lower price of Aids drug - April 11, 2007

US-based drug maker Abbott Laboratories has agreed to lower the price of its Aids drug Kaletra from 5,938 baht per patient per month to 3,488.20 baht. Siriwat Tiptaradol, the Food and Drug Administration's (FDA) secretary-general, said the new price could make Kaletra cheaper than the generic version.

The firm's proposal to cut the drug price is seen as a means to end the dispute with the Public Health Ministry over the high price of Kaletra that led to the ministry's decision to break the drug patent earlier this year.

Speaking after yesterday's meeting with representatives from patent-holding companies, Mr Siriwat said Abbott insisted that it disagreed with the issuance of compulsory licenses, so it opted for a discount on the drug's price instead.

Aids Access Foundation's director Nimit Tienudom hailed the firm's discount proposal.

"This is what the patients and health activists have been waiting for. This is apparently a consequence of the government's decision to break the drug patent," said Mr Nimit.

Abbott shuns Aids drug talks: Govt wants to discuss compensation figures  - April 09, 2007

Abbott Ltd, patent holder of the HIV/Aids treatment Kaletra, has turned down an invitation by the Food and Drug Administration (FDA) for a meeting to discuss compensation for the drug listed for compulsory licensing.

The rejection of the invitation is being seen by many as the company's attempt to show its disapproval with Thailand's move to break the company's patent for the drug, allowing the state to produce or import cheaper, generic versions.

FDA secretary-general Siriwat Thiptaradol said Abbott confirmed that it would not join tomorrow's meeting, aimed at negotiating the drug price and the royalty fee. Dr Siriwat said Abbott had told the FDA that it found the offer unacceptable.

He said, however, that representatives of MSD and Sanofi-Aventis, patent-holders of Efavirenz and the heart drug Plavix, are expected to attend the meeting.

The session will be the second round of meetings.

The first round, which was held late last month, ended inconclusively as the pharmaceutical firms told negotiators they had to discuss the matter with their parent companies.

Previously, the FDA had informed the patent holders that the state was willing to compensate them with only 0.5% of the revenue generated from the generic drug sales. This was in keeping with Article 51 of the patent law, he said.

The Public Health Ministry issued compulsory licences in November and early January to produce or import generic versions of the costly drugs for emergency use in the country.

However, Abbott bluntly rejected any offer, claiming such a state policy would only jeopardise its research and development plans for new drugs. The US-based drug company earlier opposed the government's decision to go for compulsory licensing and threatened to withhold the introduction of new drugs here, including an improved version of Kaletra.

In February, the drug company made an offer during a meeting with senior health officials at the Disease Control Department to cut the price of Kaletra used at state hospitals from 11,580 baht per patient per month to lower than 4,000 baht. There has been no further discussion on the offer.

"The state has to be responsible for all patients suffering from HIV/Aids and heart disease, while the private firms have to stick to the principle of profit making. Our standpoints are different. That's why we have to discuss this to seek the most acceptable solution for both sides," said Dr Siriwat.

Kaletra's global sales total US$1.1 billion (41.8 billion baht) annually.

However, the FDA secretary-general said he was not worried about resolute standpoint and that health officials were looking for other options of pharmaceutical products made by the company.

Representatives of both MSD and Sanofi have told the FDA all their decisions would come from discussions with their mother companies.

So far, MSD has offered to reduce the price of Efavirenz to 726 baht per bottle, but the government can buy the generic version of the anti-retroviral treatment from India at just 650 baht per bottle.

Sanofi-Aventis, however, has offered a "special package" for the heart disease drug to respond to the government's policy of extending access to medicines, and a special quota of 3.4 million tablets of Plavix for 34,000 patients in Thailand.

Dr Siriwat said the government also planned to ask Novartis to reduce the price of Gleevec, a leukaemia treatment, instead of adopting a philanthropic programme in order to genuinely extend drug access for patients suffering from cancer.

Nude snaps charity stunt snubbed by Aids temple - March 31, 2007

Wat Phra Bart Nam Phu temple, which cares for abandoned Aids patients, has turned down an offer of cash donations to be raised from an Aids charity edition of Fame magazine containing nude pictures of male and female celebrities, models and actors. The temple abbot, Phra Udom Prachathorn, widely-known as Phra Archan Alongkot, said the temple would not accept donations from such activity.

He added the temple in Lop Buri knew nothing about the plan, nor had any hand in organising it, even though the magazine may have used the temple's name in connection with the auction for the nude photos, to be held sometime between April 5-9.

The organiser had faxed the temple to say it was sending a representative to provide a cash donation.

An organiser, who declined to be named, said the magazine was having second thoughts about the project.

The Ministry of Culture also turned its nose up at the proposed charity event.

The magazine is yet to come out, but promotional pictures released this week have already caused a stir. Culture Minister Khunying Khaisri Sri-aroon said there were better ways for celebrities to raise money for Aids victims than posing nude for a magazine.

Although she conceded that some of the pictures could be regarded as "artistic" rather than simply being lewd, some of the poses were sexually provocative. One in particular showed a model bending down.

Raising funds for charity was a noble thing, but the method chosen was inappropriate, she said.

The minister was responding to reports ahead of the release of the magazine that will showcase 32 celebrities, models and actresses who posed nude to raise funds for Wat Phra Bart Nam Phu, a major sanctuary for Aids sufferers.

"Taking off your clothes for photography is a different matter [from raising money for charity]," said Prisana Pongtatsirikul, secretary-general of the Office of the National Culture Commission.

"I would like them to cover themselves. Being naked is not beautiful, nor is it a practice of decent women," she said.

Any charitable efforts should be socially responsible and keep within the boundaries of Thai culture - especially that of dress - in order to set a good example to young people.

Aids patients would be glad to receive the kind of assistance that would not adversely affect society, she said.

Drug-makers reject offer of royalty fees: More talks planned with patent holders  - March 27, 2007

The government has failed to reach an agreement with patent holders of HIV/Aids and heart drugs listed for compulsory licensing.

Royalty payments are being offered to the pharmaceutical companies whose patents will be breached when generic versions are produced locally or imported.

Food and Drug Administration secretary-general Somsak Choonharasmi, who leads the negotiations, said yesterday the FDA had informed the patent holders the state was willing to compensate them with only 0.5% of the revenue generated from the generic drug sales.

This was in keeping with Article 51 of the patent law.

But the drug companies did not accept the offer. Representatives said they needed to first discuss the matter with their mother companies before making a decision, he said.

The negotiating committee was appointed by Public Health Minister Mongkol na Songkhla.

It comprises 15 representatives from relevant agencies like the FDA and the Commerce and Foreign Affairs ministries. The committee's first round of talks with representatives of Abbott Laboratories, MSD, and Sanofi-Aventis lasted almost five hours yesterday.

Abbott owns the original Aids treatment Kaletra, while MSD and Sanofi-Aventis hold the patents to Efavirenz and the heart drug Plavix.

The Public Health Ministry issued compulsory licences in November and early January to produce or import generic versions of these costly drugs for emergency use in the country.

So far, MSD has offered to reduce the price of Efavirenz to 726 baht per bottle, but the government can buy the generic version of the anti-retroviral treatment from India at 650 baht per bottle.

Sanofi-Aventis, however, has offered a "special package" for the heart drug to serve the state policy of extending access to medicine, and a special quota of 3.4 million tablets of Plavix for 34,000 patients in Thailand, said Dr Somsak.

The FDA chief, who has asked for more details on the special Plavix package, has insisted that the quality of drugs for sale in Thailand must be the same as the existing versions being distributed in the global market.

On the other hand, Abbott continued to reject the use of compulsory licensing for its anti-Aids drugs and the offer of royalty fees by the government.

It says such a policy would only jeopardise its research and development plans for new drugs.

The company's representatives, however, did not say they would petition the Department of Intellectual Property Rights to review the policy, he said.

The US-based company earlier opposed the government's decision to go for compulsory licensing and threatened to withhold the introduction of 10 new drugs in Thailand, including an improved version of Kaletra.

The firm's decision upset both local and international health advocates.

Religious investors in Abbott Laboratories stock criticised the drug maker's decision saying the move put the health of Thais at risk, and asked the company to reconsider its decision.

Novartis yesterday offered wider access to some of its cancer drugs in Thailand through a philanthropic programme.

The Public Health Ministry was planning to extend compulsory licensing to other drug categories, including cancer, when the company relented.

The company holds the patent for Gleevec which is widely used for treating leukaemia.

Health activists have also protested at the Swiss company's decision to file a lawsuit against a generic producer in India in response to the New Delhi government's rejection of its attempt to patent a new version of the medicine.

Dr Somsak said the committee would open a second round of talks with the drug firms on April 10.

Meanwhile, the FDA said it would not take the snack brand Party off the supermarket shelves because it had no authority to do so.

A boy was sent to hospital on Sunday after drinking chemical substances from a promotional toy which came with the snack.

An FDA expert said the chemicals were magnesium stearate and sodium bicarbonate which could cause stomach ache, irritation around the neck, and chest pain.

Editorial: Putting meaning back into TRIPS - March 22, 2007

The decision by US-based Abbott Laboratories to withhold new medicines from Thailand certainly strikes at the heart of the government's efforts to secure life-saving medicine for all Thais. But the Ministry of Public Health must stand firm. Backing down now would send the wrong message to other pharmaceutical manufacturers, and deprive citizens of Thailand's rights under the World Trade Organisation's agreement on Trade-Related Aspects of Intellectual Property (TRIPS).

It could be argued that the interim government's aggressive move to issue compulsory licences for several drugs without sufficiently warning each patent holder unnecessarily led to retaliation from Abbott. Possibly more pharmaceutical companies will follow suit in the days and weeks to come.

Yet prior negotiations with drug companies, as Public Health Minister Mongkol Na Songkhla explained at length in a white paper issued last month, largely amounts to a nicety that usually proves fruitless. Worldwide experience has shown that the iron stick of threatening to issue a compulsory licence is often the only negotiating tool drug companies seem to take seriously.

Indeed, Dr Mongkol mentioned that pharmaceutical companies did not cooperate with a working group set up in 2005 to negotiate for reduced drug prices. "After one year, a short report of the working group concluded the failure of their work to reduce the price of the patented drugs," he wrote in the white paper.

Once the compulsory licences were issued, Big Pharma responded swiftly. In February, Merck agreed to lower the price for Efavirenz, the first-line Aids-fighting drug, to 700 baht per bottle from the pre-compulsory licence price of 1,400 baht.

Abbott Laboratories, by withdrawing its applications to market new drugs in Thailand, appears to be drawing a line in the sand as it hopes other countries will not start issuing compulsory licences for its drugs. Although some have argued the move is "immoral", Abbott is within its legal rights and is taking a hard-line stance - not unlike Thai policy-makers.

Although Thailand's compulsory licences are legal under TRIPS, the government could do more to reassure the international community that its overriding of patents and importing of generic drugs was made "in good faith to protect public health" and will not be "an instrument to pursue industrial or commercial policy objectives", as the WTO deal stipulates.

In this respect, the Government Pharmaceutical Organisation should open its books or reveal its strategy to cope with increased generic production. Its facilities now do not meet World Health Organisation (WHO) standards, and thus none of the drugs produced at the GPO's current factory will meet global quality standards.

Abbott's decision to withdraw its new medicines will force Thailand to import a generic version of Kaletra from India, which may not be bad for now since the GPO has yet to start building a new factory. Thai patients will rest easy knowing the drugs they are taking come from WHO pre-qualified factories, and taxpayers will be happy that money from the Global Fund to Fight Aids, Tuberculosis and Malaria can be used to pay for them.

In the meantime, Thailand's stance on compulsory licensing is important to test the TRIPS agreement. Although news wires are fond of calling Thailand's usage of compulsory licensing "technically legal" - a loaded term - the move is often blasted simply because few countries have resisted pressure from Big Pharma and certain Western governments and actually exercised their rights under TRIPS.

But, if Thailand gets criticised for following the TRIPS deal approved by every WTO member, including the United States, then what is the point of the agreement?

In issuing compulsory licences, Thailand is putting meaning back into TRIPS - and forcing a renewed global debate on an issue Big Pharma would rather handle through bilateral trade deals with weaker nations.

WHO urged to help poor countries find cheaper drugs  - March 21, 2007

Health advocacy groups yesterday urged two leading international organisations to take further steps in supporting developing countries in their efforts to win access to unaffordable medicines via compulsory licensing.

"We're wondering what the WHO [World Health Organisation] is doing apart from sending a letter to initially support the Thai government's move on compulsory licensing," said Paul Cawthorne, head of mission of the Doctors without Borders (MSF).

A group of representatives from MSF and British-based Oxfam yesterday met Suwit Wibulpolprasert, special adviser to the public health minister, to show support to the ministry's drug access policy.

They also planned to globally campaign against Abbott products after the US drug-maker last week announced that it would withhold its new products in Thailand in protest against the military-installed government's decision to override its blockbuster Aids drug Kaletra.

Dr Cawthorne believes the WHO and the UNAIDS, as two international bodies dealing directly with world population and health issues, should be more involved in this global drug patent debate and play a leading role in supporting low-income countries in their fight to access the badly needed but high quality patented medicines, despite facing pressure from pharmaceutical companies.

He said the WHO should come up with a list of essential drugs for HIV/Aids, tuberculosis and malaria. Although many have been patented, most were still regarded as generic drugs.

"It is the WHO's job to find cheaper versions of the expensive drugs for poor countries," he said. The organisation will send letters urging concrete action regarding access to generic drugs to both UNAIDS director Peter Piot and WHO director-general Margaret Chan.

Dr Chan wrote to the ministry last month expressing regrets over her much-criticised comments on a Thai government plan to produce cheaper versions of patented drugs through compulsory licensing.

She later threw her backing behind the government decision by saying that it was certainly in line with the Trade-Related Aspects on International Property Rights (TRIPS).

During a brief visit to the National Health Security Office in early February, she was adamant that negotiations with multi-national drug companies were necessary before the government could move to compulsory licensing.

P. T. Jayawickramarajah, the WHO representative in Thailand, said in an interview with the Bangkok Post recently that the organisation had encouraged 193 countries to ensure access to affordable, high quality drugs by supporting the use of flexibility within the TRIPS agreement.

The organisation also tried to educate member countries about the global framework of this international trade agreement so that they could effectively deal with the issue of drug access.

"This is all I can comment," he said.

The ministry in November overrode the patents of Aids drugs Kaletra and Efavirenz and heart drug Plavix to import cheaper generic versions for treating people suffering from the diseases claimed as national epidemics.

Activists call for boycott of US drug giant: Say Abbott's response to govt move immoral  - March 20, 2007

Activist doctors, consumer rights and Aids groups have called for a boycott of medicines and other products of US drug giant Abbott Laboratories after the firm withdrew the registration of seven new drugs in Thailand.

They said the action by the drug firm, which produces the anti-Aids drug, Kaletra, in response to the government's decision to go ahead with compulsory licensing, was immoral.

Also withdrawn are new antibiotics and other medicines for the treatment of kidney disorders, high blood pressure and constricted blood vessels.

"Abbott is acting like it is taking patients hostage in a bid to pressure the government to abandon compulsory licensing," Saree Ongsomwang, of the Foundation for Consumers, said in a statement released yesterday.

The Public Health Ministry has approved compulsory licensing that allows for the importation or production of generic versions of patented drugs so low-income patients can afford them.

Abbott's Kaletra, an advanced anti-Aids drug, is one of three medications coming under compulsory licensing. The others are the anti-Aids drug Efavirenz, and Plavix, for patients with heart disease, produced by other companies.

The activists rebuked the company for placing profit before business ethics.

"We've already asked health establishments nationwide to join the boycott," said Rural Doctors Society president Kriangsak Watcharanukulkiat.

The groups have cooperated with international heath promotion organisations such as Medicins Sans Frontieres (Doctors without Borders), to ask people in other countries to take part in the boycott.

They also threatened to expand their boycott to other types of products made by companies affiliated to Abbot, should the company still insist on withdrawing its new drugs from Thailand.

Abbot is a major producer of a wide range of products, including medicines and nutrient and milk products.

"The company's action clearly shows it is being unscrupulous," said Rosana Tositrakul, coordinator of the Anti-Corruption Network of 30 Non-Governmental Organisations.

The Public Health Ministry has applied the compulsory licensing under the Thai Patent Act that allows the country to import or produce generic and cheaper versions of patented drugs. The World Trade Organisation also allows its member nations to declare a "national emergency" as a reason to use compulsory licensing.

"It took us seven years to convince the government to approve them," said Aids Access Foundation's local director Nimit Tienudom, defending the merits of the compulsory licences.

Unlike previous governments which dared not infuriate giant drug companies, the Surayud Chulanont government had taken a courageous move to protect the rights of patients, Mr Nimit said.

"All people will fight on by your side," said Mr Nimit, in reference to Public Heath Minister Mongkol na Songkhla.

Thailand threatens to expand generic drugs for cancer, AIDS  - March 18, 2007

BANGKOK,  Thailand's health minister has threatened to expand the country's generic drug programme to include cancer and more AIDS medications, unless pharmaceutical companies sharply cut their prices.

In an interview with AFP, Health Minister Mongkol Na Songkhla said he was undeterred by the fierce resistance from drugmakers to his trailblazing drive to issue so-called "compulsory licences" for high-priced medications.

"I will continue to negotiate with drug companies" to reduce prices of AIDS, cancer and heart disease medications, Mongkol told AFP.

"But if negotiations fail, we are ready to act," the 65-year-old general practitioner said.

Under the rules of the World Trade Organisation, countries are allowed to order compulsory licenses that temporarily suspend patents and clear the way for generic drugs to protect public health in an emergency.

Few countries have actually used this provision.

But since Mongkol was appointed as health minister by the military after a September coup, he has jolted the powerful pharmaceutical industry by allowing generic versions of two anti-AIDS drugs -- Efavirenz and Kaletra -- and popular heart disease medicine Plavix.

The decision drew outrage from the industry with Thailand's top pharmaceutical group calling it "a stunning blow" to foreign investment already hit by political uncertainty since the coup.

"This is unprecedented in Thailand. If the government decides to allow more generic drugs, it will further damage the image of Thailand among international investors," said Teera Chakajnardom, president of Pharmaceutical Research and Manufacturer's Association of Thailand.

Angered by Mongkol's decision, US drug giant Abbott Laboratories, the maker of AIDS drug Kaletra, said this week it would stop selling new drugs to Thailand -- including an improved version of Kaletra.

But Mongkol was unfazed by critics and corporate retaliations, saying that after years as a ministry bureaucrat involved in price negotiations with European and US drug giants, he was well aware of his opponents.

"Our ministry has been negotiating with drug companies over the past two years" to cut drug prices, he said. "But they did not cooperate with the ministry. Never. They were never interested in negotiations.

"We've come to the point that we have to do something about it. We cannot wait and talk to them without any achievement."

Drugmakers say they have to charge high prices for new medicines to recover the enormous cost of research needed to bring new medications to market.

The minister said HIV/AIDS is Thailand's top cause of death, followed by heart disease.

Some 500,000 Thais are infected with HIV, but fewer than 10 percent of them can afford to buy Kaletra, he said.

Under the generic programme, treatment with Kaletra is expected to drop from 11,580 baht (330 dollars) per month to 4,000 baht per month, according to charity Doctors Without Borders (MSF).

Similarly, fewer than 10 percent of some 300,000 heart disease patients in Thailand can buy Plavix, a blood-thinning treatment to prevent heart attacks, according to the ministry.

The cost of Plavix, the world's second top-selling medicine, is expected to drop from 73 baht (two dollars) per day to fewer than seven baht under the generic program, the ministry said.

Paul Cawthorne, head of the MSF mission in Thailand, hailed Thailand's move and said Mongkol had complied with WTO rules.

"What the government has done so far is perfectly legal within Thai law and is also legal within the guidelines of the World Trade Organisation," said Cawthorne.

Mongkol said the government had to resort to the generic program in the face of a ballooning health care budget now at more than 250 billion baht (seven billion dollars) and projected to rise 10 percent every year.

"We want to help the poor. We have to use the compulsory licence for the poor people," he said, adding the government would import generic forms of the AIDS and heart drugs from India, a major source of copycat medications.

Former premier Thaksin Shinawatra, ousted by the military in the September putsch, set up an enormously popular health scheme allowing Thais to pay only 30 baht (about 80 US cents) for each visit to the doctor.

After the coup, the army-backed government went further by scrapping the 30-baht payment, creating a free-for-everyone health care system.

All of Thailand's 65 million people are eligible for the universal health plan unless they have coverage from their employer or qualify for other government insurance schemes.

The universal health scheme covers some 48.5 million, or 75 percent of the population, the ministry said.

Mongkol said drug giants should do more to cut prices of essential medicines to treat AIDS, cancer and heart diseases.

"If they voluntarily reduce prices to let the poor people access to essential drugs, there is no need to do compulsory licensing," he said. "We are doing everything to help the poor people."


Justice slams Abbott's drug decision  - March 16, 2007

 Jarun: Crosses the line between profit, morals .

A top justice official yesterday denounced a US drug maker's withholding of new medicines from Thailand, saying it overstepped the line between business profits and morality. "The drug industry is an obvious profit-oriented business. But its present business protection goes beyond the limit - to the extent that the principle of human rights has been completely forgotten," said Permanent Secretary for Justice Jarun Pukditanakul.

Mr Jarun was speaking after US drug firm Abbott Laboratories announced it would withdraw applications for six drugs in protest at the government's breaking of its patent for the anti-Aids drug Kaletra.

The firm said its withdrawal of applications with the Food and Drug Administration (FDA) would include the formulation of second-line Aids drugs.

Speaking on the topic of the constitution and reform of the consumer protection system to mark World Consumer Day, Mr Jarun supported the Public Health Ministry's decision to break the patent of three Aids and heart drugs in order to broaden access to medications among low-income earners.

The government had to be responsible for HIV-positive people and those suffering from chronic heart disease, he said. Therefore, it was legally and morally right to balance business profits and the good health of the public by announcing compulsory licensing.

Mr Jarun said the ministry was seeking ways to encourage public participation in the constitution drafting process in order to improve drug affordability.

Existing laws and regulations on intellectually property rights, patents and trademarks should be revised because these laws extended monopoly rights for brand-name drugs to the extent that the public's rights had been obstructed, he added.

The national list of medicines overseen by the National Health Security Office should also be closely monitored so that consumer rights would not be exploited, he said.

Saree Ongsomwang, head of the Foundation for Consumers, said consumer groups would campaign for a boycott of other Abbot products if the company did not review its decision to withdraw the applications of new drugs by Monday.

Siriwat Thiptaradol, secretary-general of the FDA, said he would have a meeting with patent holders of the three drugs under compulsory licensing on March 26.

Addressing gender and Aids: a compulsory requirement - March 9, 2007

In all too many places, women face inequality with men, but in one area they are fast approaching equality where no one wants it. Worldwide, the number of women living with HIV is almost equal to the number of men. Every day 7,000 women around the world become infected and the number is on the rise. More than 17.5 million women are now living with HIV.

In the most heavily affected countries in Africa, 59% of adults and nearly 75% of young people now living with HIV are female. In Asia, the situation is less dramatic but of serious and growing concern: 30% of adults living with HIV in Asia are women, with rates reaching 39% in Thailand and 46% in Cambodia.

Why are women catching up with men in terms of HIV infections?

One cause is the difference in physical make-up between men and women which makes women almost twice as likely to become infected with HIV from men as men are from women. But apart from the biological inequality there are many deeply rooted social patterns which explain why women are increasingly becoming infected with HIV.

Many social norms and patterns across the world can influence the adoption of behaviour that increases the risk of HIV infection. In many areas of the world, suspicion of immorality and infidelity threaten women's fragile status and scares them away from carrying or insisting on using a condom. For the same reasons, women will also avoid routine reproductive health services where they could be informed about HIV, be tested and if needed receive treatment.

Social norms also encourage men to engage in risky behaviour which puts them, but also their female partners, at greater risk of HIV infection.

For too many men across the world, seeking health care and information, and taking adequate responsibility for their sexual or reproductive health represents a challenge to their masculinity.

On the other hand, a multiplicity of sexual partners and violence against female partners may be considered as expressions of male power and strength.

We need to look carefully at subjects still taboo in many societies - men and women's place in society and their sexuality, often based on privilege and power or burdened by coercion, ignorance and violence. Twenty-five years into the epidemic and 65 million infections later, it is long past time to confront these issues and challenge the nature of relations between men and women which makes both sexes vulnerable to HIV.

To stop the feminisation of the epidemic, as well as the epidemic itself, we have to initiate legal but also social, cultural and economic changes to challenge some of the most pervasive social patterns and gender norms that continue to fuel the Aids epidemic.

We must start judging our responses to HIV by two questions: do they promote the human rights of women and girls and do they promote the responsibilities of men and boys?

For example, do they prioritise sending all girls to school to receive a proper education, including sexual education as well as life skills training? Do they respect women's rights to control when, with whom and under what circumstances they have sexual relations? Do they sanction violence, inside and outside marriage? Do they create room for women to participate in the public debate and decision-making? Do they protect women's economic autonomy by securing their property and inheritance rights? Do they aim to deliver on female-controlled HIV prevention methods?

To succeed against HIV, Asia, like everywhere, must ensure that all its citizens, men and women, girls and boys, are equal and full players in this necessary shift in paradigm.

Women, inside and outside the home, must have the economic, social and political power to stand up for their rights and protect themselves and their families from violence and disease, and men must question those aspects of privilege and power that put themselves, their sexual partners and their offspring at risk.

Above all, men and women have to agree to change together the society they live in for one respectful of the individual and of human rights.

This paradigm shift is necessary to beat HIV, it has become a compulsory requirement to get ahead of this epidemic.

Peter Piot is UNAids Executive Director.

Saving lives via compulsory licensing  - March 2, 2007
 

To guarantee public access to affordable drugs, it is suggested that the compulsory licensing clause be incorporated in the new constitution

Thailand's daring step in enacting compulsory licensing for three patented Aids and heart disease medications - Efavirenz, Kaletra and Plavix - consecutively within two months is being seen as a pivotal move by developing countries in widening access to necessary medicines for their populations. The swift action was praised by HIV/Aids and consumer rights activists the world over, as much probably as it has upset big pharmaceutical firms, which are seeking ways to protect their business interests and intellectual property rights through legal bodies, both domestically and internationally.

It is understandable why the Public Health Ministry led by Mongkol na Songkhla quickly sought to implement the compulsory licensing clause allowed by the World Trade Organisation to produce or import generic versions of patented drugs for government use, as he only has a limited time to work in this position. However, it remains to be seen how he and his team completes their work and prepares the Health Ministry and related agencies to find a balance between the price war with drug companies and the sustainable expansion of public access to quality, affordable medicine.

In November, Dr Mongkol issued a compulsory licence for Merck's HIV/Aids drug Efavirenz followed by the second-line combination antiretroviral therapy Kaletra and heart disease drug Plavix in January - the first non-Aids drug to be included in the compulsory licensing list by a developing nation.

"We have to bear the financial burden in taking care of these diseases which are regarded as national epidemics. Expanding public access to medicine is very essential for us and compulsory licensing is our last resort to deal with the matter," Dr Mongkol said.

The army-appointed interim minister said health researchers had studied the problem of overpriced drugs for over five years, but none of the previous health ministers had taken action.

He decided to put the measure into effect because the ministry has long faced a tough time in negotiating with drug firms.

Evidently, the move seemed to be very effective in opening a long-awaited dialogue between the ministry and drug firms on the issue of overpriced drugs.

Right after the announcement was made, pharmaceutical groups immediately sought to negotiate with the ministry. Merck, for example, offered an official price-cut for its patented Efavirenz the world over including in Thailand. Still, the health agency questioned why should it want to return to buying the original drug when a cheaper version was available from India. The new prices for Kaletra and Plavix have yet to be agreed on between the state and private companies.

The drug firms have their own ways of defending their multi-billion-dollar businesses. They have sought help from the Department of Intellectual Property to forward the issue to the Council of State. They probably hope that the Health Ministry's action regarding drug procurement could end up the same way as its previous, futile attempt to ban alcohol advertisement.

Although Dr Mongkol has repeatedly explained that his action was in accordance with the WTO's agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to import or produce copycats of these medicinal pills for government use, and that a white paper had been distributed explaining his actions to the public, sceptics remained doubtful whether this policy would be applied to other essential drugs - especially after a future, elected minister takes over Dr Mongkol's position.

Teera Chakajnarodom, president of the Pharmaceutical Research and Manufacturers Association, said he did not believe the future government would continue to carry out this policy. This was mainly because the Government Pharmaceutical Organisation itself had limited capacity to manufacture affordable drugs to meet public demand or to counter epidemics by itself.

"The GPO won't be able to produce generic medicines which contain the therapeutic equivalance of original ones, when its drug-manufacturing plant is not even up to standard," he said, claiming that research and development for each original drug cost up to US$1-1.5 billion.

The GPO does indeed have limited manufacturing capacity. Its present plant in Bangkok, located in the heart of the city, is overcrowded and has not passed the Good Manufacturing Practice (GMP) certification of the World Health Organisation.

Its new, larger plant has yet to be constructed even though the project has been planned for almost a decade, mainly because of transparency problems.

Undoubtedly, the flaw can be easily targeted and criticised by multinational drug firms. What's the point of issuing compulsory licences when the preparation for this new role of producing copycats of medicines for government use remains up in the air?

Although the agency is in the process of developing a laboratory for producing the generic version of Aids and heart disease drugs, and it is expected to be completed by the end of the year, the GPO requires much overhauling if the ministry truly wants to achieve its announced goal of widening the public's access to cheap but quality drugs.

Vithaya Kulsomboon, a health expert from Chulalongkorn University's Faculty of Pharmaceutical Sciences, said the GPO needed an incentive to do more research and development work. A substantial portion from its annual profit should be earmarked for boosting R&D - even though the amount could not be compared to the sums invested by big drug firms.

Apart from changes at the GPO itself, it is important that the public sector regard this experience of compulsory licensing as a stepping stone in a bid to deal with the issue of drug access after this government finishes its term, he said.

Mr Vithaya believed the best way to guarantee that the issue of public access to affordable quality drugs is carried on by the future government would be to incorporate it into the new constitution.

Now was also the best time since the Thai-US free trade agreement has been put on hold.

The bilateral trade agreement includes the issue of "data exclusivity" which guarantees additional market protection for originator pharmaceuticals by preventing authorities from accepting applications for approval of generic medicines during the period of exclusivity, usually 6 to 10 years.

By embodying this detail, the trade agreement could hinder the country's public healthcare system as a whole. This could result in the Thai people having to buy overpriced drugs indefinitely, unless the country could come up with some legal immunity against the bilateral agreement, he said.

The onus is on multinational pharmaceuticals themselves, too, to adjust their marketing strategies in developing countries where the issue of overpriced drugs is a serious impediment to public health.

"Every sector involved needs to fine-tune its standpoint in order to seek the right balance between the issue of drug price and public access. After all, medicines are not ordinary commodities. In many instances, they are life-saving tools," Mr Vithaya said.

GPO chief claims unfair dismissal: Sacked by cabinet for failing to follow policy  - March 1, 2007

The managing director of the Government Pharmaceutical Organisation has been sacked by the cabinet following a personal row with the board chairman and what he said yesterday was unfair pressure to speed up the upgrading of a pharmaceutical manufacturing plant and the breaking of international drug patents. Mongkol Jivasantikarn said Public Health Minister Mongkol na Songkhla's comments on his failure to implement government policy on developing vaccines and drugs "necessary for the country" were baseless.

Lt-Gen Mongkol said the budget preparation for constructing vaccine development plants had already been drafted and the Government Pharmaceutical Organisation (GPO) would be ready to produce oseltamivir for bird flu within a month.

The sacking of Lt-Gen Mongkol was approved by the cabinet on Tuesday on the grounds that he had failed to turn health policy into action. He will work in the position until a successor is selected.

Lt-Gen Mongkol also claimed it was unreasonable to blame the substandard drug manufacturing plant on him, saying examination of the facilities by the World Health Organisation was carried out before he was appointed in Oct 2005.

He said that he and other GPO executives had been put under pressure by the issue of compulsory licensing.

He said it was difficult to speed up the government's policy to break the patents on Aids drugs and heart disease therapy as long as there was no guarantee from policymakers that they would be protected from any possible lawsuits by patent holders of the drugs if they signed contracts to approve the import or manufacture of generic versions.

He criticised board chairman Vichai Chokewiwat, saying Dr Vichai had overstepped the line. The chairman's duty was to oversee the broad picture of GPO policy, not to directly supervise the managing director, Lt-Gen Mongkol said.

"Of course, I can't do everything to please everyone within a short period of one year. But I can assure you that everything that I've done has been in the GPO's best interests," he said at a press conference attended by hundreds of GPO staff.

Rawai Poopaka, president of the GPO staff union, said the decision to terminate his contract was suspicious.

Mr Rawai demanded an explanation from the health minister and the GPO chairman, saying "we will not leave this issue unexplained".

Dr Vichai declined to clarify the reasons which led to the dismissal of the managing director but said the decision was based on facts and was agreed to by the board.

Compulsory Patents Debate: Dept denies seekingruling on licensing  - February 15, 2007

The Intellectual Property Department yesterday denied it had sought a ruling on the Public Health Ministry's decision to enforce compulsory licensing on drugs.

Department chief Puangrat Asavapisit told Aids activists led by the Aids Access Foundation, Doctors without Borders and non-government organisations that the agency had not sought advice from the Council of State, but the department was considering legal arguments raised by pharmaceutical firms.

Drug manufacturers have questioned Thailand's decision, asking whether it flouted drug patents.

The department would mediate if the Public Health Ministry and multinational drug companies could not settle the issue, he said.

The Public Health Ministry said it would impose compulsory licences for the import and production of generic versions of anti-retroviral Aids drug Efavirenz, and Kaletra, and Plavix, which are heart disease drugs.

Nimit Tienudom, director of the Aids Access Foundation, said activists opposed any move to ask the Council of State, the state's legal arm, whether the government could issue patent-overriding licences for generic versions of heart and HIV/Aids pills. They met the department chief yesterday to pass on the message.

"Thailand has been praised the world over for taking the bold step of issuing compulsory licences for expanding public access to drugs. Any drug companies feeling that their intellectual property rights are violated should take a case to the Administrative Court," he said.

Merck & Co, patent holder of Aids drug Efavirenz, last month asked the Commerce Ministry, which oversees the department, to start talks between the company and the Public Health Ministry over the ministry's plan.

Mr Nimit said the Intellectual Property Department should not be doing the drug firms' bidding, by pushing for a legal opinion. Instead, it should try to settle on an acceptable royalty fee which the state must pay the patented drug holder when compulsory licensing is imposed.

Under that regime, the drug patent owner is eligible to receive a royalty fee of up to 5% of the market value of its product.

Dangers Of Unprotected Sex: Teens must beware of STDs too, says doctor  - February 15, 2007

Teenagers having unprotected sex should be concerned not only with unwanted pregnancies but also a list of dangerous sexually transmitted diseases, including ones that can lead to cervical cancer, a leading paediatrician has warned.

The doctor said there were a number of reasons why teenage girls should say "no" to their boyfriends who ask for sex as a way to test the strength of their love.

Dr Suriyadeo Tripathi, chief of the Adolescent Clinic under the Queen Sirikit National Institute of Child Health, said reports by the United Nations Children's Fund (Unicef) showed that over the past few years, more than 60% of Thais aged between 15-24 were at risk of contracting STDs within a year of having lost their virginity.

"Some teenage girls start to protect themselves by using condoms or contraceptive pills within a year after having sex for the first time. But only 20% use condoms regularly," said Dr Suriyadeo on Tuesday.

Unicef figures show that up to 60,000 teenagers aged 15-19 have contracted HIV/Aids because of unsafe sex and that the disease is now the second most common cause of death for teenagers after accidents.

"Chronic diseases from sexual relationships are what's threatening Thai teenagers, especially girls now," said Dr Suriyadeo.

He said the most common STDs among teenage girls are gonorrhea and chlamydia, which could cause pelvic inflammation, ectopic pregnancy and infection with the human papillomavirus (HPV) which is a cause of cervical cancer.

"Most cases of HPV infection show no symptoms and 80% will recover in a few years, but 20% become chronic and have a higher risk of developing cervical cancer," said Dr Suriyadeo.

The problem with Thai teenagers, however, is that they are embarrassed or afraid to tell their parents when they contract the diseases, making the problems even worse, he warned.

To try and protect teenagers from the risk, Dr Suriyadeo urged the media to be more responsible by refraining from stimulating sexual temptations among young people.

He also suggested a campaign be launched calling on teenagers to stick to the four "No's," - no 'open invitations', no seductive behavior, no 'going too far', and no alcohol.

Compulsory Drug Licensing: Ministry pushes ahead with patent breaking  - February 13, 2007

Thailand is pushing ahead with its plan to give the public better access to more medicines under the patents of pharmaceutical giants.

Public Health Minister Mongkol na Songkhla yesterday said experts from the ministry and the National Health Security Office were studying the pros and cons of adopting compulsory licensing for use with the five groups of medicine still under patent in Thailand.

"As a matter of fact, we don't want to use the compulsory licensing policy because we don't want to upset the pharmaceutical industry. However, we have to think about the many Thais who need the medicines badly but cannot have them," Dr Mongkol said.

The five groups comprising 11 regimens cover Aids, antibiotics, cancer, heart and cardiovascular and neuropathic drugs, including atazanavir and second-line anti-retroviral treatments and inatinib, a cancer drug marketed as Gleevec/Glivec, according to a study by a sub-panel on compulsory licensing.

Patent holder Novartis last month filed a lawsuit against the government of India following its refusal to grant a patent for the cancer drug. Dr Mongkol said the panel had submitted the drug list many years ago, but it had never been considered by any government in the past.

Cancer and heart disease rank as the top causes of death in Thailand.

Although the plan has not yet been finalised and the drug list may be subject to change, the minister said he was confident that any state move to gain access to inexpensive drugs would not discourage medical companies from investing in the development of new drugs in Thailand.

He also hoped that the policy on compulsory licensing would lead to a dialogue between health authorities and the pharmaceutical industry over public access to inexpensive and quality medical treatment over the long run.

A report released by the Drug Control Division showed that more than 1,000 new companies registered with the Food and Drug Administration in 2005 to carry out pharmaceutical manufacturing in Thailand, while the total cost of imported drugs in the same year came to nearly 39 billion baht.

Meanwhile, Teera Chakajnarodom, president of the Pharmaceutical Research and Manufacturers Association of Thailand, said he was disappointed with the ministry's latest move on compulsory licensing for the import and production of generic versions of the anti-Aids drugs Efavirenz and Kaletra, and Plavix, a heart disease medicine.

Peter Piot, executive director of UNAids, commended Thailand for stressing efforts to provide affordable access to Efavirenz for people living with HIV/Aids.

Vichai Chokewiwat, chairman of the Government Pharmaceutical Organisation's board, said the "white paper" on compulsory licensing would be completed within the week.

Thailand in Talks on Cheaper AIDS Drugs - February 09, 2007

Thailand's military-backed government said today it has begun talks with Abbott Laboratories over the price of Kaletra. Last week, Thailand issued a "compulsory license" allowing it to import or produce a generic version of the AIDS drug. Abbott has now agreed to work with Thailand to lower Kaletra's cost, the ministry of health said.

"Abbott has agreed in principle with the Thai government to make Kaletra more affordable for all Thais," said Suvit Wibulpolprasert, the ministry's senior advisor on health economics. "They have not yet agreed to cut the price, but we are in negotiations over that."

Thailand's 2002 decision to begin producing its own generic version of triple-drug combination AIDS therapy resulted in an 18-fold cost reduction. AIDS deaths in the nation were down by 75 percent last year.

AIDS advocates said Thailand could cut the cost of Kaletra from 11,580 baht ($331 US) to 4,000 baht ($114 US) by using a generic.

In November, Thailand decided to allow generic versions of Merck & Co.'s efavirenz. Merck agreed to cut its price from 1,300 baht ($38.69 US) to 880 baht ($26.19 US); Thailand is importing the Indian version for 650 baht ($19.34 US), said Suvit..

Editorial: Generic drugs under assault - February 7, 2007

A Bangkok Post editorial last week ("The bottom line is people's health", Jan 31) rightly pointed out that in granting compulsory licences for the anti-Aids drug Kaletra and the heart medication Plavix on Jan 29, as well as earlier for Efavirenz, another HIV medication, the Public Health Ministry is well within compliance with the World Trade Organisation's agreement on Trade-related aspects of Intellectual Property Rights (TRIPS), signed by all WTO members in 2001. Yet there have already been high-level visits on behalf of multinational pharmaceutical companies to attempt to persuade the interim government to abide by "TRIPS-plus" measures. A major assault on access to life-sustaining generic drugs is taking place in India, however. Previously, India's patent law was restricted to process, not product, and then only for seven years. In other words, if a drug patented by a Western pharmaceutical company could be produced by a different process in India, it could be produced without breaking the country's patent law.

This provision enabled India to become the undisputed generics manufacturing centre of the world, much to the displeasure of Western pharmaceutical companies.

Since April 2005, Indian patent law has been modified to adhere to TRIPS provisions that recognise international patents on drug products for a period of 20 years, unless it can be shown that the patents don't involve any "innovative molecular research" _ a provision fully within TRIPS guidelines.

Since the passage of the 2005 law, many generic drugs manufactured in India have been shut down. Yet India, like Thailand, is also being pressured to implement measures which it feels go beyond WTO guidelines. In a landmark case, the Swiss drug giant Novartis AG is appealing in an Indian court over the rejection of a patent for its modified leukaemia drug Gleevac on the grounds that it is not sufficiently innovative. The treatment costs for Gleevac and the generic copy per month are about US$2,000 and $175, respectively (about 70,000 and 6,125 baht). There are signs that the Indian parliament is bending to corporate pressure. It has introduced a report for court consideration which recommends a lessening of the degree of innovation required for a new patent. The worry is that a patent for most drugs could be extended merely by making minor modifications, as happens routinely in the US and other Western countries. This would represent a significant threat to accessibility of generic drugs not only in India, but throughout the developing world.

Another legal obstacle to generic drugs in India is looming. Multinational companies want to forbid generics manufacturers from using their data from clinical trials in proving the safety of drugs coming off-patent. This would make the licensing process for the generics much more time-consuming and expensive.

It is too simple to demonise multinational pharmaceutical companies. Some of them, including Novartis, have in some cases been willing to make life-sustaining drugs available to those most in need at little or no cost. As long as profit remains the bottom line, however, it is a sure thing that choices will be made which limit access to essential drugs, and diseases that affect mostly poor people, such as TB and malaria, will continue to be underfunded.

Perhaps what is really needed is a system that is driven by global health needs rather than by profit. Preliminary efforts toward this objective were begun at the World Health Organisation's World Health Assembly 2006. An inter-governmental working group was set up to develop a global strategy to address TRIPS-plus disputes. The working group was also charged with coming up with proposals on how to "ensure an enhanced and sustainable basis for health research" and direct research to address diseases that affect mostly developing countries, something that would require large increases in R&D spending by governments and international organisations.

Move to break drug patents lauded - Experts: WHO should back Thai intentions  - February 3, 2007

Thailand can go ahead with the compulsory licensing of anti-Aids and heart disease drugs without having to negotiate with pharmaceutical firms as suggested by the World Health Organisation (WHO), international health policy and intellectual properties rights experts said yesterday. The country's decision to break the patents of the medicines was for government use; therefore, it could issue the compulsory licences without giving prior notice to drug manufacturers, said Carlos Correa, director of the University of Buenos Aires' science and technology policy programme.

Under the World Trade Organisation's Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips), a member country can break drug patents without letting the firms involved know if the move was to produce or import the patented drugs for government use.

The compulsory licensing also covers non-Aids related drugs.

"Several developing countries have granted licensing, especially for anti-Aids drugs. Even the US government has benefited from the mechanism. Therefore, the Thai government's move is fully compatible with international law and practice," said Dr Correa.

He also played down concerns that compulsory licensing would discourage medical firms from investing in new drug development, saying the scheme would cause only a minor impact on the drug industry, which could still make massive profits from selling new products.

The academic was one of the representatives from leading international non-governmental organisations and academic institutes, which held a joint press conference in Bangkok yesterday to voice their support for the Public Health Ministry's decision to break the patents on the drugs.

The move came after the government's endorsement of compulsory licensing to produce generic versions of the anti-Aids drug Kaletra and the blood thinner Plavix came up against fierce resistance from pharmaceutical firms, which threatened to put drug investments in Thailand on hold.

WHO director-general Margaret Chan also cautioned Thailand over the move and urged the government to begin negotiations with drug firms to strike the right balance in accessing drugs both in terms of quality and quantity.

Martin Khor, director of the Malaysia-based Third World Network, said under Trips, a country is not required to negotiate with the patent owners if the compulsory licensing is for government or non-commercial uses.

Thailand's case was in accordance with this rule, he said.

The government should resist the pressure from the pharmaceutical industry and stand firm on its decision to produce cheap drugs for patients in need, said Mr Khor.

Health experts and activists taking part in the press conference also expressed disappointment with the WHO's view on the patent breaking.

Instead of raising concerns about the move, they said, the WHO should have praised Thailand for issuing the compulsory licences, which would allow Thais greater access to affordable drugs.

The groups, including Medecins Sans Frontieres and the Bangkok-based Aids Access Foundation, called on the world health body to revert to its role of serving the public interest, and support the move to apply compulsory licensing.

Editorial: Your medication: Is it genuine? - February 3, 2007

Any mention of copyright violations usually brings to mind pirated DVDs, software, music and the challenges posed to legitimate, paying users by error-prone and frustrating digital rights management programs designed to combat such infringements. It can all sound relatively harmless and create the misconception among some people that piracy is essentially a victimless crime. This is definitely not the case. The singer or musician whose work is stolen is a victim, and the Thai software engineer whose work is copied without recompense loses his livelihood. What is rightfully theirs goes into the pockets of criminal gangs.

But the most sinister aspect of this trade in fake goods, and one those people who try to rationalise taking advantage of and making such purchases usually overlook, is that counterfeiting is all-pervasive, with few areas left untouched. Consumers are in danger of discovering just how widespread and hazardous it can be when the medicine they buy from the pharmacy or clinic, or the new brake linings they purchase for their car, also turn out to be masquerading under a fake brand name. The likelihood is that these counterfeits will be substandard and possess the potential to seriously harm or kill them. A frighteningly true example of caveat emptor or let the buyer beware.

The counterfeiting of ordinary medicines has become big business for unscrupulous criminal gangs and, tragically, it continues to be a growth industry with truly horrific results. One pharmacist in the United States was even convicted of adulterating and counterfeiting cancer treatment drugs so he could enrich himself by increasing the suffering of cancer victims. He was caught, but arrest rates in our part of the world are ominously low.

There is no shortage of international concern. The World Health Organisation (WHO), World Bank and Interpol have long expressed concern at the proliferation of counterfeit medicines and they were joined this week by the World Intellectual Property Organisation, which took up the matter at its annual meeting in Geneva. Industry specialists put the cost of such counterfeiting at more than $100 billion a year and warned just how much it was putting human health and safety at risk while, at the same time, undermining economic development through lost earnings, lost jobs and lost tax revenues.

Delegates did not raise any eyebrows when members of the organisation declared China to be the worst offender in the trade of fake goods, with every product on the market being a target for counterfeiters. They already knew that two-thirds of all bogus goods seized by European Union customs officials came from China. But they could not fail to be shocked at hearing that 10% of the world's medicines are fakes. And this was a conservative estimate. The WHO believes that up to 25% of prescription drugs sold in developing countries are pirated and consequently a menace to public health.

The most commonly counterfeited medicines are treatments for life-threatening conditions such as HIV/Aids, tuberculosis and, especially, drug-resistant malaria. The malaria problem, endemic in border areas, is worsened by the roaring trade in fakes, including the new and effective Artemisinin-based Combination Therapy (ACT) drugs. The counterfeiters follow where people are buying these drugs, counterfeit them and put them on the market and all of a sudden, the medicine stops working. For the drugs to be safe and effective, they have to be what they say they are. Patients die when they are not.

The Public Health Ministry publishes photos of seized counterfeits on its website. Its researchers say they regard China as the main instigator because only 5% of the contents of some of its drugs are medical substances while over 90% can be just glucose.

Concerted efforts are being made to stem the flow, but this problem needs to be tackled at the source, which puts the onus on Beijing - a regime which has shown just how tough it can get when it really wants to. Ending this despicable trade in human suffering and greed should provide sufficient impetus to act.

Phoned Pill Reminders Make Inroads Against TB - February 02, 2007

A mobile phone pilot project in Chiang Mai has improved the province's tuberculosis treatment success rate tremendously. TB treatment failure has long been associated with patients' inconsistency in taking their medicines, prompting the project to use an inexpensive calling promotion to remind them when it is time to take their antibiotics.

For three months, 60 patients on a six-month TB treatment have received daily reminder phone calls. The patients were given a phone with a calling promotion that allows them to receive only incoming calls. Trained volunteers who are former TB patients telephone daily to remind the patients to take their medicine.

Dr. Surasing Visrutarana, chief provincial health officer, said the program's outcome has been very promising. The drug- taking consistency rate for the patients was more than 90 percent.

According to the Public Health Ministry, Thailand has around 90,000 new TB cases each year, or about 50 per 100,000 people. Every year, 12,000 Thais die of the infection. Thailand is included in the list of 22 "high-burden countries," alongside Mozambique, Zimbabwe, Uganda, and Cambodia.

Surasing said the project has benefited from the knowledge of the volunteers. "To my amazement, the daily call is not just a good reminder to those patients who forget to take the drug, but it also comes in a way that makes them feel cared about and supported," he said. "This leads to better cooperation on the part of the patients."

The pilot project will be concluded in the next three months, said Surasing, who hailed it as a success, especially given its low cost, just 100 baht ($3 US) per person.

WHO raps compulsory licensing plan: Govt urged to seek talks with drug firms  - February 2, 2007

The World Health Organisation yesterday cautioned Thailand over its move to adopt compulsory licensing for producing generic versions of heart disease and anti-Aids drugs.

"I'd like to underline that we have to find a right balance for compulsory licensing. We can't be naive about this. There is no perfect solution for accessing drugs in both quality and quantity," said WHO director-general Margaret Chan.

Speaking during a visit to the National Health Security Office, Dr Chan said she truly felt that the pharmaceutical industry was part of the solution to better drug access and that the government should open negotiations with drug firms over the issue.

She encouraged the Public Health Ministry to improve the public-private partnership in order to give the public better access to drugs. Public Health Minister Mongkol na Songkhla declined to comment on the issue.

The president of Aids Access Foundation, Nimit Tienudom, dismissed the WHO director-general's standpoint. "It's disappointing. The organisation should have supported drug access and promoted the study of quality and inexpensive drugs for the sake of the global population rather than supporting pharmaceutical giants."

The ministry last week endorsed a policy for the compulsory licensing of two drugs - Kaletra, an advanced anti-Aids drug, and Plavix, a treatment for heart disease by invoking Article 51 of the 1992 Patent Law to import or produce a generic version of the two drugs.

In November, the ministry issued the same law to import and produce the anti-Aids drug Efavirenz, resulting in a reduction in the price from 1,400 baht to 700 baht per monthly course.

Plavix will cost just six baht per tablet under compulsory licensing, while the original price was 70 baht. The patented regimen of the second-line anti-retroviral drug costs 11,580 baht a month per patient and this could be cut to a third under compulsory licensing.

Thailand is the first developing country to invoke compulsory licensing under the World Trade Organisation's rules for a non-Aids related drug. The WTO allows a government to declare a "national emergency" and license the production or sale of a patented drug for state use. The patent holder would receive royalties equal to 0.5% of the annual sales, according to the ministerial plan.

About 108,000 of 500,000 people living with HIV/Aids depend on GPO-VIR, the generic version of the first-line anti-retroviral therapy produced by the Government Pharmaceutical Organisation. An estimated 20,000 HIV-positive people have developed resistance to the drug, and need a combination of lopinavir and ritonavir, which is marketed as Kaletra.

However the country's Pharmaceutical Research and Manufacturers Association disapproves of the decision, claiming that compulsory licensing could result in more companies relinquishing patents for heart and anti-Aids drugs and that it could lead to the isolation of Thailand from the global biotechnology investment community.

Kaletra is manufactured by Abbott Laboratories, and Plavix by Sanofi-Aventis and Bristol-Myers Squibb.

Editorial: The bottom line is people's health  - January 31, 2007

In issuing compulsory licences for the heart drug Plavix and anti-Aids drug Kaletra, the Public Health Ministry is taking a bold step to ensure Thailand takes full advantage of the World Trade Organisation's agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), signed by the US and all other WTO members in 2001.

Let us quickly recall what it says. At the Doha ministerial conference in 2001, the declaration on TRIPS and public health clearly states that the agreement "does not and should not prevent members from taking measures to protect public health". It goes on to say the agreement "can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all". To this end, it also says: "Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted."

Article 31 of Part 2 of the TRIPS agreement also states that no negotiations with the patent holder are required in cases of national emergency, extreme urgency or public non-commercial use. While heart disease, a top killer here, has not been declared a national emergency like HIV/Aids, the compulsory licence for Plavix complies with WTO rules based on public non-commercial use. If patent holders question the legal validity of the compulsory licences issued by the government over the past few months, they have a right to bring the case to court.

We applaud the government for using all legal methods possible to ensure Thai patients get the cheapest and best drugs available. At the same time, the government should be careful not to unnecessarily further push away foreign investment. Just because the government is not legally required to negotiate with drug companies before issuing a compulsory licence doesn't mean it should not do so. It would do no harm to ask the drug companies first to lower prices to a level comparable to generic drugs. If they refuse, then the government can still issue a compulsory licence. But at least the government will have acknowledged that intellectual property rights ought to be respected in Thailand.

In issuing the compulsory licence, the government should also insist on procuring quality drugs. This means importing them from factories approved by the World Health Organisation. This is particularly vital when it comes to HIV/Aids drugs. Poor quality drugs can increase resistance rates, making it necessary to keep issuing compulsory licences for expensive innovative drugs, which Western pharmaceutical companies spend large amounts of money to research and develop. Just as we acknowledge our right to provide these drugs for our people, we also must ensure we produce generic versions responsibly. Right now, the Government Pharmaceutical Organisation's facilities are not up to WHO standards. The government still has not started construction on a factory outside of Bangkok that meets international standards despite passing a resolution four years ago saying it would build one. Although GPO and government officials say Thailand's generic Aids drugs are of high quality, it would be nice to remove the cloud of suspicion. We hope the government would put patients first and import the cheaper, quality generics from India until construction of a new GPO facility is complete. If the government does this, it will be able to procure drugs with money from the Global Fund to Fight Aids, Tuberculosis and Malaria. The fund refuses to finance Thai-produced drugs because they don't meet international standards.

The money saved could be used to expand patient education. Much of the resistance to Thai generic HIV/Aids drugs is attributed to patients who misunderstand how to take the drugs. This is unacceptable. What is the point of expanding drug coverage if the drugs will prove ineffective due to incorrect usage? All in all, we support the government's efforts to make life-saving drugs affordable. But more work must be done to show the world we are responsible leaders in public health.

Project aims to reduce rate of STDs along Thai-Lao border  - January 29, 2007

Ubon Ratchathani - The provincial public health office in Ubon Ratchathani has launched a project to curb sexually transmitted diseases (STDs) and Aids along the Thai-Lao border.

The project is primarily aimed at helping local women working in karaoke bars, who sometimes become involved in prostitution.

Provincial public health officer Wutthikrai Mungmai said under the project, medical services and anti-HIV advice will be offered to people crossing the Chong Mek border checkpoint.

Up to 5,000 people visit the crossing on Saturdays and Sundays, he said.

The project has been undertaken with the collaboration of Champasak province of Laos and a non-profit organisation.

"A report says the number of HIV and Aids patients in Ubon Ratchathani has reached more than 3,000 and is likely to be on the increase," Dr Wutthikrai said, adding that Thailand and Laos have maintained constant communication and shared information to seek ways to change the behaviour of high-risk groups.

A centre called Ban Khan Eng (Friendly House) has been set up to provide advice on preventing HIV and STDs.

Doctors and nurses from Sirindhorn Hospital in Ubon Ratchathani's Sirindhorn district, will pay voluntary visits and offer medical services every other Wednesday.

 

Thailand to break patents on AIDS, heart drugs - Thu Jan 25

BANGKOK  - Thailand has said it will break the patents on two AIDS and heart disease drugs, prompting a swift threat from pharmaceutical firms to review their investment plans in the kingdom.

"The public health minister gave us the guidelines to overrule the patents in order to make the drugs more accessible to poor patients by lowering the price of the drugs," health ministry spokesman Suphan Srithamma told AFP.

"The drugs are for AIDS ( Kaletra ) and heart disease ( Plavix ). These two drugs have patents overseas and are expensive here," he said.

The announcement came less than two months after Thailand decided to issue a "compulsory licenses" for pharmaceutical giant Merck's high-priced

HIV/AIDS drug Efavirenz.

AIDS activists praised the decision to break that patent, halving the cost of the medication, but pharmaceutical companies condemned the move as a threat to their intellectual property rights.

With Thailand set to use generic versions of more drugs, the Pharmaceutical Research and Manufacturers' Association (PReMA) warned that companies would reassess their plans for investment in the kingdom.

"Leading members of the association have been stunned by these statements and have confirmed to me that their plans for further investment in Thailand will be put on hold pending a review of the foreign investment climate," PReMA president Teera Chakajnarodom said in a statement.

"They are concerned about continuing to invest in a country where the government cannot provide a basic guarantee for the safety of their assets."

The World Trade Organisation allows governments to declare a "national emergency" and produce generic versions of patented drugs without the permission of the drug's maker.

But Teera said the health ministry had taken its decision without consulting pharmaceutical firms and accused the government of using an overly broad definition of an emergency.

"The law allows such actions with pharmaceutical products only in cases of extreme national emergencies, or during wartime, and only after negotiation with the companies concerned," he said.

"It is a provision in the law that has to be used judiciously and with extreme caution if one is not to undermine the confidence of the investment community."

International companies are still reeling from proposals to tighten rules on foreign investments in Thailand, which have dampened investor confidence in the country that underwent a military coup just four months ago.

Thailand's universal HIV/AIDS treatment programme has been hailed as a success in the fight against the disease, largely because of the country's ability to provide anti-retroviral drugs to patients.

In 2002, the Thai government launched a generic version of HIV/AIDS triple therapy and was able to cut the cost of treatment 18-fold.

Thailand's treatment program has been widely credited with slashing the number of deaths from AIDS by about 75 percent last year and the number of new annual HIV infections continues to drop.

Top drug firms delay investing here: Anger at govt plan to license generic drugs  -  January 25, 2007

Giant pharmaceutical firms have put further investment in Thailand on hold in response to the Public Health Ministry's decision to seek compulsory licences for cheap versions of drugs to treat heart disease and Aids. "Leading pharmaceutical manufacturers have been stunned by the statement and have confirmed that their plans for further investment in Thailand will be stalled pending a review of the foreign investment climate," Teera Chakajnarodom, president of the Pharmaceutical Research and Manufacturers Association, said in a statement released yesterday.

The pharmaceutical industry's swift protest came after Public Health Minister Mongkol na Songkhla said on Wednesday that the government will press ahead with its plan for compulsory licensing to allow imports of generic versions of the drugs.

Dr Mongkol said this would alleviate some of the financial burden on the ministry and patients caused by the high cost of patented imported drugs.

The World Trade Organisation allows governments to declare a "national emergency" and produce or import generic versions of patented drugs.

Enraged pharmaceutical manufacturers lashed out at the decision, saying it would hit the basic guarantee of the safety of investors' assets. They accused the government of acting without consultation with the pharmaceutical industry.

"We fully appreciate the health challenges and financial constraints that the ministry faces. However, the best response to this situation is to engage constructively with industry to find a mutually agreeable solution," said Mr Teera.

He said the government's plan to force more companies to relinquish patents for heart and anti-Aids medicine would lead to the isolation of Thailand from the global biotechnology investment community.

"This step has undone the many years of work that biotechnology companies have undertaken to convince their head offices that Thailand is attractive for the life sciences industry," he said.

The international health promotion organisation Medicins Sans Frontieres (MSF), meanwhile, hailed the ministry's decision to issue a compulsory licence as a "perfectly legal method ... to ensure access to essential drugs for Thai people".

Paul Cawthorne, head of the MSF, said each Thai HIV/Aids patient spent about 11,580 baht a month for the Aids drug Kaletra. This could be cut by two thirds if there was a generic alternative.

 

 

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